Oral Curcumin for Radiation Dermatitis
The purpose of the study is to determine whether curcumin, an ingredient of some foods, can prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues..
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients|
- To evaluate the degree to which curcumin can reduce radiation-induced skin reactions in breast cancer patients receiving radiotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients).
- How curcumin can prevent or decrease the incidence of moist desquamation, redness and pain at treatment site [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Secondary outcome measures will be moist desquamation (i.e., RDS 3.5 or higher), redness at treatment site (EI), and pain at treatment site Short-Form McGill Pain Questionnaire (SF-MPQ-2), taking into consideration the degree to which curcumin can decrease the incidence of moist desquamation, as well as the number of sites of moist desquamation, and to decrease the number of treatment interruptions due to skin reactions.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Other Name: Curcumin C3 Complex
Radiation is a toxic agent and a widely accepted form of treatment for various types of cancer. Approximately half of all women with breast cancer receive radiation therapy. Despite advances in medical technology, radiation therapy still causes severe skin effects. Radiation dermatitis occurs in approximately 90% of patients and ranges in severity from mild redness to more severe skin changes. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it; currently, there is no standard treatment for the prevention of radiation-induced dermatitis. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues.
|Principal Investigator:||Julie Ryan, PhD, MPH||University of Rochester|