NCT01246973

Oral Curcumin for Radiation Dermatitis

Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 686 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 21 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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..

Detailed description

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.

Conditions

• Radiation-induced Dermatitis

Interventions

Type	Name	Description
DRUG	Curcumin	4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
DRUG	Placebo	4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-11-01
• Completion: 2015-01-01
• First posted: 2010-11-24
• Last updated: 2016-03-07
• Results posted: 2016-03-07