Oral Curcumin for Radiation Dermatitis

• ClinicalTrials.gov Identifier: NCT01246973
• Recruitment Status: Completed
• First Posted: November 24, 2010
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016
• Sponsor: University of Rochester
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Julie Ryan, University of Rochester

Study Description

Brief 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..

Condition or disease	Intervention/treatment	Phase
Radiation-induced Dermatitis	Drug: Curcumin; Drug: Placebo	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 686 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients
• Study Start Date: February 2011
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: January 2015

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Mean Radiation Dermatitis Severity Score [ Time Frame: 6 weeks ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Rochester

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Julie Ryan, PhD, MPH; University of Rochester

More Information

• Responsible Party: Julie Ryan, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01246973
• Obsolete Identifiers: NCT01238198
• Other Study ID Numbers: URCC 10054; URCC 09005 ( Other Identifier: NCI ); U10CA037420 ( U.S. NIH Grant/Contract ); URCC 10054 ( Other Identifier: University of Rochester )
• First Posted: November 24, 2010
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016
• Last Verified: February 2016

Keywords provided by Julie Ryan, University of Rochester:

Oral Curcumin; Radiation Dermatitis; Breast Cancer Patients

Additional relevant MeSH terms:

Dermatitis; Radiodermatitis; Skin Diseases; Radiation Injuries; Wounds and Injuries; Curcumin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action