Breast Carcinoma
Conditions
Brief summary
This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments. SECONDARY OBJECTIVES: I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments. II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application. III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream. IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream. OUTLINE: Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.
Interventions
Given topically
PROCEDUREManagement of Therapy Complications
Receive fluocinonide cream
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention * Vaginal dryness or dyspareunia must be present for at least two months prior to study entry * Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study * Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream * Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance * Subjects must sign informed consent * Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent
Exclusion criteria
* Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days) * Use of any estrogen containing medications, products, or preparations * Use of any systemic oral or parenteral steroid containing medications is not permitted; use of High Daily Dose inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than High Daily Dose is permitted * Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia * Subject reported symptoms of vaginal infection with significant vaginal discharge or odor * Known current vaginal infection * Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms * Known intolerance of topical steroid preparations * Pregnant or lactating women (to be obtained via subject report only) * Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or Cushing's syndrome * No prior chemotherapeutic treatment for any malignancy other than breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Scores of Vaginal Dryness | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Symptom Scores of Dyspareunia | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Experiencing Toxicities | Over 4 weeks | Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set. |
| Change in Vaginal Dryness Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Dyspareunia Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Itching Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Dyspareunia Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Symptom Scores of Vaginal Itching | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics | Baseline and 4 weeks | Association of response in symptoms with patient reported compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients |
| Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics | Baseline and 4 weeks | Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients |
| Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics | Baseline and 4 weeks | Association of response in symptoms with patient reported compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients |
| Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics | Baseline and 4 weeks | Association of response in symptoms with tube weight based compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight. |
| Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics | Baseline and 4 weeks | Association of response in symptoms with tube weight based compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight. |
| Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics | Baseline and 4 weeks | Association of response in symptoms with tube weight based compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight. |
| Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Change in Total Vaginal Index Score. | Baseline and 4 weeks | Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Supportive Care |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 55.44 years STANDARD_DEVIATION 9.39 |
| Current endocrine therapy Anastrazole | 7 Participants |
| Current endocrine therapy Exemestane | 3 Participants |
| Current endocrine therapy Letrozole | 13 Participants |
| Current endocrine therapy Tamoxifen | 11 Participants |
| Indications for endocrine therapy Adjuvant | 33 Participants |
| Indications for endocrine therapy Prophylaxis | 1 Participants |
| Menopause status Post-menopausal | 33 Participants |
| Menopause status Pre-menopausal | 1 Participants |
| Prior cytotoxic chemotherapy received No prior cytotoxic chemotherapy | 20 Participants |
| Prior cytotoxic chemotherapy received Prior cytotoxic chemotherapy | 14 Participants |
| Severe baseline symptoms, Dryness Not severe | 19 Participants |
| Severe baseline symptoms, Dryness Severe | 15 Participants |
| Severe baseline symptoms, Dyspareunia Missing/not reported | 9 Participants |
| Severe baseline symptoms, Dyspareunia Not severe | 10 Participants |
| Severe baseline symptoms, Dyspareunia Severe | 15 Participants |
| Severe baseline symptoms, Itching Not severe | 33 Participants |
| Severe baseline symptoms, Itching Severe | 1 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 24 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Change in Symptom Scores of Dyspareunia
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Symptom Scores of Dyspareunia | -2 units on a scale |
Comparison: The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.p-value: 0.002Wilcoxon (Mann-Whitney)
Comparison: GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2p-value: 0.06295% CI: [0, 1.09]McNemar
Primary
Change in Symptom Scores of Vaginal Dryness
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Symptom Scores of Vaginal Dryness | -2 units on a scale |
Comparison: The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2p-value: 0.00195% CI: [0, 0.36]McNemar
Secondary
Change in Dyspareunia Symptom Scores by Age Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Age Characteristics | Age 18-45 | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Age Characteristics | Age 46-55 | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Age Characteristics | Age 56-65 | -2.5 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Age Characteristics | Age > 65 | -3 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.2678ANOVA
Secondary
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics | Anastrazole | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics | Exemestane | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics | Letrozole | -2.5 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics | Tamoxifen | -1.5 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.8772ANOVA
Secondary
Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics | Adjuvant | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics | Prophylaxis | NA units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.4937ANOVA
Secondary
Change in Dyspareunia Symptom Scores by Menopause Status Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Menopause Status Characteristics | Pre-Menopause | NA units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Menopause Status Characteristics | Post-menopause | -2 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.3676ANOVA
Secondary
Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics
Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics | 50 - 74% | NA units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics | >= 75% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics | Missing / not reported | NA units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.3676ANOVA
Secondary
Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics | Yes | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics | No | -2.5 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.5113ANOVA
Secondary
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics
Association of response in symptoms with tube weight based compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics | < 25% | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics | 25 - 49% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics | 50 - 74% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics | >= 75% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics | Missing / not reported | -3 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.2011ANOVA
Secondary
Change in Symptom Scores of Vaginal Itching
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Symptom Scores of Vaginal Itching | -1 units on a scale |
Comparison: The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Total Vaginal Index Score.
Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Total Vaginal Index Score. | -5 units on a scale |
Comparison: The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.p-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
Change in Vaginal Dryness Symptom Scores by Age Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Age Characteristics | Age 18-45 | -1.5 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Age Characteristics | Age 46-55 | -2.0 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Age Characteristics | Age 56-65 | -2.0 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Age Characteristics | Age > 65 | -2.0 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.1029ANOVA
Secondary
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics | Anastrazole | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics | Exemestane | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics | Letrozole | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics | Tamoxifen | -2 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.6587ANOVA
Secondary
Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics | Adjuvant | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics | Prophylaxis | -3 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.7983ANOVA
Secondary
Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics | Pre-Menopause | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics | Post-menopause | -2 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.507ANOVA
Secondary
Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics
Association of response in symptoms with patient reported compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics | 50 - 74% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics | >= 75% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics | Missing / not reported | NA units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.507ANOVA
Secondary
Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics | Yes | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics | No | -2 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.9618ANOVA
Secondary
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics
Association of response in symptoms with tube weight based compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics | < 25% | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics | 25 - 49% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics | 50 - 74% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics | >= 75% | -2 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics | Missing / not reported | -2.5 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.08531ANOVA
Secondary
Change in Vaginal Itching Symptom Scores by Age Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Age Characteristics | Age 18-45 | -0.5 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Age Characteristics | Age 46-55 | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Age Characteristics | Age 56-65 | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Age Characteristics | Age > 65 | -0.5 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.2472ANOVA
Secondary
Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics | Anastrazole | -0.5 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics | Exemestane | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics | Letrozole | -0.5 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics | Tamoxifen | -1 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.7395ANOVA
Secondary
Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics | Adjuvant | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics | Prophylaxis | -2 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.9106ANOVA
Secondary
Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics | Post-menopause | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics | Pre-Menopause | -1 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.6023ANOVA
Secondary
Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics
Association of response in symptoms with patient reported compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics | 50 - 74% | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics | >= 75% | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics | Missing / not reported | NA units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.6023ANOVA
Secondary
Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics
Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics | Yes | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics | No | -1 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.8833ANOVA
Secondary
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics
Association of response in symptoms with tube weight based compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time frame: Baseline and 4 weeks
Population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics | < 25% | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics | 25 - 49% | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics | 50 - 74% | 0 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics | >= 75% | -1 units on a scale |
| Supportive Care (Fluocinonide Cream) | Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics | Missing / not reported | -1 units on a scale |
Comparison: In order to compare the response between groups, Kruskal-Wallis ANOVA was used.p-value: 0.1187ANOVA
Secondary
Number of Patients Experiencing Toxicities
Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.
Time frame: Over 4 weeks
Population: Toxicity and safety analyses will be conducted using the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Fluocinonide Cream) | Number of Patients Experiencing Toxicities | 1 Participants |