Breast Cancer, Dermatologic Complications, Radiation Toxicity, Skin Reactions Secondary to Radiation Therapy
Conditions
Keywords
dermatologic complications, skin reactions secondary to radiation therapy, radiation toxicity, breast cancer in situ, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer, ductal breast carcinoma in situ, stage IV breast cancer
Brief summary
RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis. PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.
Detailed description
OBJECTIVES: Primary * Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ. Secondary * Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs. * Compare the time to onset and duration of severe radiation dermatitis in these patients. * Assess skin toxicity and quality of life of these patients. * Assess the adverse event profile of mometasone furoate in these patients. * Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to radiation field (breast \[post-lumpectomy\] vs chest wall \[post-mastectomy\]), regional lymph nodes (treated vs not treated), and planned total radiation dose (including boost) (50-55 Gy vs \> 55 Gy). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy. * Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in arm I. Patients complete questionnaires and a symptom experience diary at baseline and periodically during study for quality of life, skin toxicity, and adverse event assessment. After completion of radiotherapy, patients are followed for 2 weeks. PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
Interventions
DRUGmometasone furoate
Applied to treatment area
OTHERplacebo
Applied to treatment area
Sponsors
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ * Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites: * Whole breast (as part of breast-conservation therapy) * Chest wall (as part of post-mastectomy irradiation) * Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed * Must meet the following criteria for planned radiotherapy: * Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy * No planned split-course radiotherapy * No partial breast treatment, defined as treatment of \< 75% of the breast parenchyma * Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed * Must be entered on study within 7 days prior to beginning radiotherapy * Must start study drug prior to receiving the third radiotherapy fraction * No preexisting skin breakdown within the planned radiotherapy field at the time of study entry * No bilateral breast cancer treatment * No inflammatory carcinoma of the breast * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to complete questionnaires independently or with assistance * No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy to the planned radiotherapy treatment area * No concurrent or planned leukotriene inhibitors, including the following: * Zafirleukast * Monteleukast * Zileuton * No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments: * Cortaid® * Cortizone 10® * Tucks® * Preparation H® * No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. | During Radiation Treatment, up to a maximum of 9 weeks. | Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | During Radiation Treatment, up to a maximum of 9 weeks. | Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity. |
| Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). | During Radiation Treatment, up to a maximum of 11 weeks. | Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity). |
| Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis. | During Radiation Treatment, up to a maximum of 9 weeks. | To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis. |
| Incidence of Severe ( Grade >=3) Radiation Dermatitis | During Radiation Treatment, up to a maximum of 9 weeks. | To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. |
| QOL Domains as Measured by LASA | During Radiation Treatment, up to a maximum of 11 weeks. | Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale. |
| Adverse Events Assessed Clinically by NCI CTCAE v3.0 | During Radiation Treatment, up to a maximum of 9 weeks. | — |
| Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | During Radiation Treatment, up to a maximum of 11 weeks. | Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better) |
| Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) | During Radiation Treatment, up to a maximum of 11 weeks. | Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL). |
Countries
United States
Participant flow
Recruitment details
Total of 176 patients were enrolled on this trial between 9/21/07 and 12/07/2007. There were 7 cancels (5 in Arm A and 2 in Arm B) and 3 patients discontinued treatment (1 in Arm A and 2 in Arm B). In total 84 in Arm A and 82 in Arm B were evaluable for the primary endpoint.
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy. | 85 |
| Placebo Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B. | 84 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancel | 5 | 2 |
| Overall Study | Discontinued Mometasone/Placebo | 1 | 2 |
Baseline characteristics
| Characteristic | Mometasone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60 years FULL_RANGE 14.63 | 57 years FULL_RANGE 11.8 | 59 years FULL_RANGE 13.29 |
| Region of Enrollment United States | 85 participants | 84 participants | 169 participants |
| Sex: Female, Male Female | 85 Participants | 84 Participants | 169 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 | — / — | — / — |
| other Total, other adverse events | 75 / 84 | 81 / 82 |
| serious Total, serious adverse events | 0 / 84 | 0 / 82 |
Outcome results
Primary
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).
Time frame: During Radiation Treatment, up to a maximum of 9 weeks.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mometasone | Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. | 1.2 Grade |
| Placebo | Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. | 1.3 Grade |
p-value: 0.18t-test, 2 sided
Secondary
Adverse Events Assessed Clinically by NCI CTCAE v3.0
Time frame: During Radiation Treatment, up to a maximum of 9 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | ARTHRALGIA: Severe | 1 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | BURN: Mild | 32 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | BURN: Moderate | 6 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | BURN: Severe | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | CELLULITES INFECTN: Moderate | 1 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | COUGH: Severe | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | DERMATOLOGY: Mild | 11 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | DERMATOLOGY: Moderate | 8 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | DERMATOLOGY: Severe | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | FATIGUE: Moderate | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PAIN: Severe | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PAIN-BREAST: Moderate | 1 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PAIN-CHEST: Moderate | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PRURITUS: Mild | 36 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PRURITUS: Moderate | 14 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PRURITUS: Severe | 1 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN ATROPHY: Mild | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN ATROPHY: Moderate | 1 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN HYPOPIGMENT: Mild | 5 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN HYPOPIGMENT: Moderate | 1 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN IRRITATION: Moderate | 0 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN STRIAE: Mild | 2 participants |
| Mometasone | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN STRIAE: Moderate | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PAIN-BREAST: Moderate | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | ARTHRALGIA: Severe | 0 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN ATROPHY: Moderate | 0 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | BURN: Mild | 32 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PAIN-CHEST: Moderate | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | BURN: Moderate | 5 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN IRRITATION: Moderate | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | BURN: Severe | 2 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PRURITUS: Mild | 50 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | CELLULITES INFECTN: Moderate | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN HYPOPIGMENT: Mild | 8 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | COUGH: Severe | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PRURITUS: Moderate | 14 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | DERMATOLOGY: Mild | 19 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN STRIAE: Moderate | 0 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | DERMATOLOGY: Moderate | 3 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PRURITUS: Severe | 5 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | DERMATOLOGY: Severe | 2 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN HYPOPIGMENT: Moderate | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | FATIGUE: Moderate | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN ATROPHY: Mild | 2 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | PAIN: Severe | 1 participants |
| Placebo | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | SKIN STRIAE: Mild | 6 participants |
Secondary
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)
Time frame: During Radiation Treatment, up to a maximum of 11 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Dry Peeling | 2.7 units on a scale | Standard Deviation 3.33 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Swelling | 2.3 units on a scale | Standard Deviation 3.29 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Weeping | 1.2 units on a scale | Standard Deviation 2.77 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Fatigue | 4.5 units on a scale | Standard Deviation 3.06 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Wet Peeling | 1.3 units on a scale | Standard Deviation 2.65 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Decrease in color | 2.3 units on a scale | Standard Deviation 3.12 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Rash | 2.6 units on a scale | Standard Deviation 3.38 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Band, Stripes or Lines | 1.7 units on a scale | Standard Deviation 2.8 |
| Mometasone | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Redness | 5.1 units on a scale | Standard Deviation 3.52 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Band, Stripes or Lines | 1.5 units on a scale | Standard Deviation 2.66 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Redness | 6.8 units on a scale | Standard Deviation 3.34 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Dry Peeling | 3.1 units on a scale | Standard Deviation 3.66 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Wet Peeling | 1.6 units on a scale | Standard Deviation 3.14 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Weeping | 1.4 units on a scale | Standard Deviation 2.86 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Rash | 4.0 units on a scale | Standard Deviation 3.96 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Swelling | 2.4 units on a scale | Standard Deviation 3.14 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Fatigue | 5.0 units on a scale | Standard Deviation 3.11 |
| Placebo | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Decrease in color | 2.1 units on a scale | Standard Deviation 2.81 |
Secondary
Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.
To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.
Time frame: During Radiation Treatment, up to a maximum of 9 weeks.
Population: This analysis was not completed due to too little incidence of the dermatitis.
Secondary
Incidence of Severe ( Grade >=3) Radiation Dermatitis
To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.
Time frame: During Radiation Treatment, up to a maximum of 9 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone | Incidence of Severe ( Grade >=3) Radiation Dermatitis | Experience grade >=3 radiation dermatitis | 4 Paticipants |
| Mometasone | Incidence of Severe ( Grade >=3) Radiation Dermatitis | Did not experience grade >=3 radiation dermatitis | 80 Paticipants |
| Placebo | Incidence of Severe ( Grade >=3) Radiation Dermatitis | Did not experience grade >=3 radiation dermatitis | 78 Paticipants |
| Placebo | Incidence of Severe ( Grade >=3) Radiation Dermatitis | Experience grade >=3 radiation dermatitis | 4 Paticipants |
Secondary
Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)
Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).
Time frame: During Radiation Treatment, up to a maximum of 11 weeks.
Population: Patients who completed at least 1 assessment were evaluable for this secondary end point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone | Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) | 85 units on a scale | Standard Deviation 16 |
| Placebo | Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) | 82 units on a scale | Standard Deviation 19 |
Secondary
QOL Domains as Measured by LASA
Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.
Time frame: During Radiation Treatment, up to a maximum of 11 weeks.
Population: Patients who completed at least 1 assessment were evaluable for this secondary end point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | QOL Domains as Measured by LASA | Physical well-being | 83 units on a scale | Standard Deviation 17 |
| Mometasone | QOL Domains as Measured by LASA | Social well-being | 81 units on a scale | Standard Deviation 19 |
| Mometasone | QOL Domains as Measured by LASA | Emotional well-being | 85 units on a scale | Standard Deviation 16 |
| Mometasone | QOL Domains as Measured by LASA | Spiritual well-being | 89 units on a scale | Standard Deviation 14 |
| Mometasone | QOL Domains as Measured by LASA | Mental well-being | 86 units on a scale | Standard Deviation 15 |
| Placebo | QOL Domains as Measured by LASA | Spiritual well-being | 84 units on a scale | Standard Deviation 21 |
| Placebo | QOL Domains as Measured by LASA | Mental well-being | 84 units on a scale | Standard Deviation 18 |
| Placebo | QOL Domains as Measured by LASA | Physical well-being | 79 units on a scale | Standard Deviation 19 |
| Placebo | QOL Domains as Measured by LASA | Emotional well-being | 80 units on a scale | Standard Deviation 19 |
| Placebo | QOL Domains as Measured by LASA | Social well-being | 77 units on a scale | Standard Deviation 24 |
Secondary
Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).
Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).
Time frame: During Radiation Treatment, up to a maximum of 11 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone | Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). | 1.4 score on a 0-6 scale | Standard Deviation 1.24 |
| Placebo | Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). | 1.7 score on a 0-6 scale | Standard Deviation 1.35 |
Secondary
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool
Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.
Time frame: During Radiation Treatment, up to a maximum of 9 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Discomfort/Burning | 1.5 Score on a 0 to 5 scale | Standard Deviation 1.69 |
| Mometasone | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Itching | 1.5 Score on a 0 to 5 scale | Standard Deviation 1.53 |
| Mometasone | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Pulling | 1.0 Score on a 0 to 5 scale | Standard Deviation 1.36 |
| Mometasone | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Discomfort/Tenderness | 2.1 Score on a 0 to 5 scale | Standard Deviation 1.57 |
| Placebo | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Discomfort/Tenderness | 2.5 Score on a 0 to 5 scale | Standard Deviation 1.61 |
| Placebo | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Discomfort/Burning | 2.1 Score on a 0 to 5 scale | Standard Deviation 1.74 |
| Placebo | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Pulling | 1.4 Score on a 0 to 5 scale | Standard Deviation 1.66 |
| Placebo | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | STAT: Itching | 2.2 Score on a 0 to 5 scale | Standard Deviation 1.47 |