Who is sponsoring NCT01042938?

NCT01042938 is sponsored by University of Rochester.

What condition does NCT01042938 study?

NCT01042938 studies Breast Cancer.

What drugs are being tested in NCT01042938?

Interventions: Curcumin C3 Complex, Placebo.

What is the status of NCT01042938?

NCT01042938 is currently COMPLETED.

Last reviewed 2012-06-19 · How we verify

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

NCT01042938 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	University of Rochester
Phase	Phase 2
Status	COMPLETED
Enrolment	35
Start date	2008-01
Completion	2011-04

Conditions

Breast Cancer

Interventions

Curcumin C3 Complex
Placebo

Primary outcomes

Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients — 4-7 weeks (prescribed course of radiation)
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.

Countries

United States