Conditions: Breast Carcinoma Pain Radiation-Induced Dermatitis Stage 0 Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 191
Healthy volunteers: no

Brief summary:
This randomized pilot phase II trial studies and compares prophylactic topical agents in reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss and inflammation during radiation therapy.

Detailed description:
PRIMARY OBJECTIVE:

I. To investigate the effectiveness of Curcumin gel (curcumin-based gel) or HPR Plus™ in reducing radiation dermatitis in breast cancer patients.

Arms:
arm 1: Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. arm 2: Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. arm 3: Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.

Interventions: intervention 1: Curcumin-based Gel intervention 2: Dermatologic Complications Management intervention 3: Laboratory Biomarker Analysis intervention 4: Placebo intervention 5: Questionnaire Administration
Intervention descriptions: intervention 1: Applied topically intervention 2: Apply HPR Plus topically intervention 3: Correlative studies intervention 4: Apply placebo gel topically intervention 5: Ancillary studies

Protocol document: