drugset / Trial / NCT01042938

Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients

NCT01042938

Phase 2 Completed 35 enrolled University of Rochester
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-01
Primary completion
2010-09
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Curcumin Small molecule 2 g Oral

Indications