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Brief Title: Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Official Title: Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Study ID: NCT01042938
Brief Summary: Ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. Despite advances in medical technology, radiation therapy still causes severe early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of patients. Important consequences of radiation-induced dermatitis include impairment of the quality of a patient's life due to pain and premature interruption of radiation treatment, which in turn, may be impair good local control of disease. The biological pathways responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural phenolic compound found in both turmeric and curry powders, can prevent or alleviate radiation-induced skin reactions in breast cancer patients receiving radiotherapy.
Detailed Description: 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.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Rochester Medical Center & Wilmot Cancer Center, Rochester, New York, United States
Name: Julie L Ryan, PhD, MPH
Affiliation: University of Rochester Medical Center & Wilmot Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Julie L Ryan, PhD, MPH
Affiliation: University of Rochester Medical Center & Wilmot Cancer Center
Role: STUDY_CHAIR
Name: Alice P Pentland, MD
Affiliation: University of Rochester Medical Center & Wilmot Cancer Center
Role: STUDY_CHAIR
Name: Marilyn Ling, MD
Affiliation: University of Rochester Medical Center & Wilmot Cancer Center
Role: STUDY_CHAIR