Trial intelligence / Profile preview

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

NCT01042938Phase 2

Key facts

Status: Completed
Start: Jan 2008
Primary completion: Sep 2010
Countries: 1
Sponsor: University of Rochester
Modality: Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules

Drugs: curcumin
Conditions: radiation-induced dermatitis (RID)

Overview

Phase 2, randomised, double-blind trial in radiation-induced dermatitis (RID) comparing Curcumin C3 Complex with Placebo (2 arms). Primary endpoint: Severity of Dermatitis in Radiation Treatment Site. Started Jan 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

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

Who it enrols

Female patients aged 21 and older with non-inflammatory breast adenocarcinoma referred for post-operative radiotherapy without concurrent chemotherapy.

Endpoints

Primary

Severity of Dermatitis in Radiation Treatment Site4-7 weeks

Secondary

Moist Desquamation at Radiation Treatment Site4-7 weeks
Redness at Radiation Treatment Site4-7 weeks
Pain at Radiation Treatment Site4-7 weeks

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