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

NCT01042938 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-06-25

Study results available
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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.

Conditions

Interventions

DRUG

Curcumin C3 Complex

Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

DRUG

Placebo

Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Julie L Ryan, PhD, MPH · University of Rochester Medical Center & Wilmot Cancer Center

  • Julie L Ryan, PhD, MPH · University of Rochester Medical Center & Wilmot Cancer Center

  • Alice P Pentland, MD · University of Rochester Medical Center & Wilmot Cancer Center

  • Marilyn Ling, MD · University of Rochester Medical Center & Wilmot Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-09-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042938 on ClinicalTrials.gov