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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
176
Applied to treatment area
Applied to treatment area
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic, PC
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.
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.
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.
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.
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.
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.
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.
Adverse Events Assessed Clinically by NCI CTCAE v3.0
Time frame: 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)
Time frame: During Radiation Treatment, up to a maximum of 11 weeks.
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