Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Specifically, this clinical pilot study will develop data necessary to calculate a sample
size for a larger study to be conducted through the National Cancer Institute (NCI)
Community Clinical Oncology Program (CCOP) mechanism. Specifically, this pilot project will
investigate: 1) if curcumin can prevent or alleviate radiation-induced skin reactions in
cancer patients receiving radiotherapy and 2) if skin pigmentation, as well as pain and
psychophysiological factors, can predict the severity of radiation-induced dermatitis.
Potential future research studies may be conducted to identify the biological mechanisms
involved in radiation-induced dermatitis and the radioprotective function of curcumin.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients
The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.
4-7 weeks (prescribed course of radiation)
Julie L Ryan, PhD, MPH
University of Rochester Medical Center & Wilmot Cancer Center
United States: Food and Drug Administration
|University of Rochester Medical Center & Wilmot Cancer Center||Rochester, New York 14642|