Oral Curcumin for Radiation Dermatitis

Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients

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..

Study Overview

• Status: Completed
• Conditions: Radiation-induced Dermatitis
• Intervention / Treatment: Drug: Curcumin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 686
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• a diagnosis of non-inflammatory breast adenocarcinoma (including in situ and bilateral)
• scheduled to begin radiotherapy without concurrent chemotherapy; concurrent hormone or Herceptin® (trastuzumab)treatment is okay
• can have been treated by lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment
• can have had breast reconstruction
• scheduled to receive 25-35 radiation treatment sessions (1 session per day) using standard irradiation fractionation (1.8-2.0 Gy per sessions) OR 16-20 radiation treatment sessions (1 session per day) using Canadian irradiation fractionation (2.2-3.0 Gy per session)(100, 101).
• able to swallow medication.
• three weeks must have elapsed after chemotherapy and surgery before the patient can begin the study
• able to understand English

Exclusion Criteria:

• inflammatory breast cancer
• previous radiation therapy to the breast or chest
• concurrent chemotherapy treatment
• concurrent treatment with anti-coagulants (e.g., coumadin®, warfarin®), or anti-EGFR (human epidermal growth factor receptor) drugs (e.g. Iressa® (gefitinib), Erbitux® (cetuximab, C225); aspirin is allowed
• known radiosensitivity syndromes (e.g., Ataxia-telangiectasia)
• collagen vascular disease, unhealed surgical sites, or breast infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: curcumin; 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week	Drug: Curcumin; 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week; Other Names: Curcumin C3 Complex
Placebo Comparator: Placebo; 4 placebo capsules 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Radiation Dermatitis Severity Score	The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients). The RDS score ranges from 0-4 with higher scores indicating worse outcome.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Moist Desquamation	Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.	6 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 7, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Radiation Dermatitis; Oral Curcumin; Breast Cancer Patients
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: URCC 10054 (Other Identifier: University of Rochester); U10CA037420 (U.S. NIH Grant/Contract); URCC 09005 (Other Identifier: NCI)