Clinical trial NCT00438659
Conditions: Breast Cancer Dermatologic Complications Radiation Toxicity Skin Reactions Secondary to Radiation Therapy
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
Sponsor: North Central Cancer Treatment Group
Start date: 2007-08-01; Completion date: 2014-06-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy. arm 2: Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.
Interventions: intervention 1: mometasone furoate intervention 2: placebo
Intervention descriptions: intervention 1: Applied to treatment area intervention 2: Applied to treatment area

Protocol documents: