Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy

Conditions
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Breast Cancer, Dermatologic Complications, Radiation Toxicity, Skin Reactions Secondary to Radiation Therapy

Intervention / Treatment
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* Drug: mometasone furoate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone<br>Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy. | Drug: mometasone furoate<br>* Applied to treatment area<br>|
| Placebo Comparator: Placebo<br>Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I. | Other: placebo<br>* Applied to treatment area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | During Radiation Treatment, up to a maximum of 9 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During Radiation Treatment, up to a maximum of 9 weeks. | 
| 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. | During Radiation Treatment, up to a maximum of 9 weeks. | 
| 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). | During Radiation Treatment, up to a maximum of 11 weeks. | 
| 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. | During Radiation Treatment, up to a maximum of 9 weeks. | 
| 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). | During Radiation Treatment, up to a maximum of 11 weeks. | 
| 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. | During Radiation Treatment, up to a maximum of 11 weeks. | 
| 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). | Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better) | During Radiation Treatment, up to a maximum of 11 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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