Oral Curcumin for Radiation Dermatitis

NCT ID: NCT01246973

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 686 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-01-31

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..

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

curcumin

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

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

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

Placebo

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Interventions

Curcumin

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

Intervention Type: DRUG

Placebo

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Intervention Type: DRUG

Other Intervention Names

Curcumin C3 Complex

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Julie Ryan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Ryan, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Other Identifiers

URCC 09005

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA037420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

URCC 10054

Identifier Type: OTHER

Identifier Source: secondary_id

URCC 10054

Identifier Type: -

Identifier Source: org_study_id

NCT01238198

Identifier Type: -

Identifier Source: nct_alias