Invasive Breast Cancer
Conditions
Keywords
Breast cancer, Status post mastectomy, plan to receive PMRT, Topical, steroid cream, emollient skin care, Eucerin, Mometasone Furoate 0.1%
Brief summary
The purpose of this study is to find out if the effect of mometasone furoate is any different from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing the skin from peeling, or reducing the amount of irritation the patient reports during treatment.
Interventions
OTHEREucerin
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC * Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT * ECOG Performance Status of 0 or 1
Exclusion criteria
* Male * Patients with clinical evidence of gross disease * Patients who are pregnant or breastfeeding * Prior radiation therapy to the ipsilateral chest wall or thorax * Patients requiring a chest wall boost * Concurrent chemotherapy (biologic agents are allowed) * Psychiatric illness that would prevent the patient from giving informed consent * Inability or unwillingness to comply with skin care instructions and follow-up * Allergy to either Eucerin or MF * Residual grade \>1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT * Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) * Treatment with palliative or pre-operative radiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Moist Desquamation | 2 years | Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment | 5 weeks and Baseline | The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment. |
| Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up | 2 weeks after end of Radiation Therapy | The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eucerin Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.
Eucerin | 73 |
| Mometasone Furoate 0.1% Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.
Mometasone F | 70 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Treatment discontinued | 6 | 3 |
| Overall Study | Withdrawn before start | 7 | 3 |
Baseline characteristics
| Characteristic | Eucerin | Total | Mometasone Furoate 0.1% |
|---|---|---|---|
| Age, Continuous | 49 years | 49 years | 48 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 25 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) White | 49 Participants | 95 Participants | 46 Participants |
| Region of Enrollment United States | 73 Participants | 143 Participants | 70 Participants |
| Sex: Female, Male Female | 73 Participants | 143 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 73 | 6 / 70 |
| other Total, other adverse events | 25 / 73 | 29 / 70 |
| serious Total, serious adverse events | 3 / 73 | 3 / 70 |
Outcome results
Primary
Percentage of Participants With Moist Desquamation
Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eucerin | Percentage of Participants With Moist Desquamation | 66.7 % of participants w/moist desquamation |
| Mometasone Furoate 0.1% | Percentage of Participants With Moist Desquamation | 43.8 % of participants w/moist desquamation |
Secondary
Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up
The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment.
Time frame: 2 weeks after end of Radiation Therapy
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Eucerin | Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up | Emotions | 15.0 scores on a scale | Standard Deviation 12.3 |
| Eucerin | Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up | Symptoms | 11.0 scores on a scale | Standard Deviation 7.4 |
| Eucerin | Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up | Functioning | 6.0 scores on a scale | Standard Deviation 7.9 |
| Mometasone Furoate 0.1% | Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up | Emotions | 12.0 scores on a scale | Standard Deviation 12.8 |
| Mometasone Furoate 0.1% | Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up | Symptoms | 11.0 scores on a scale | Standard Deviation 6.7 |
| Mometasone Furoate 0.1% | Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up | Functioning | 5.0 scores on a scale | Standard Deviation 9.1 |
Secondary
Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment
The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment.
Time frame: 5 weeks and Baseline
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Eucerin | Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment | Emotions | 8.0 score on a scale | Standard Deviation 11.4 |
| Eucerin | Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment | Symptoms | 6.0 score on a scale | Standard Deviation 7.2 |
| Eucerin | Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment | Functioning | 2.0 score on a scale | Standard Deviation 7.4 |
| Mometasone Furoate 0.1% | Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment | Emotions | 5.0 score on a scale | Standard Deviation 9.1 |
| Mometasone Furoate 0.1% | Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment | Symptoms | 6.0 score on a scale | Standard Deviation 6.4 |
| Mometasone Furoate 0.1% | Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment | Functioning | 1.0 score on a scale | Standard Deviation 5.3 |