Oral Curcumin for Radiation Dermatitis

NCT01246973 | Completed Phase 2 Results DMC

• 3 other identifiers: URCC 10054URCC 09005U10CA037420
• Study Type: interventional
• Target: 686
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Radiation-induced Dermatitis

Keywords

Oral Curcumin; Radiation Dermatitis; Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Subjects With Moist Desquamation

  6 weeks

Study Arms (2)

curcumin

EXPERIMENTAL

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

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Curcumin DRUG

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

Also known as: Curcumin C3 Complex

curcumin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Radiodermatitis

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Julie Ryan
• Organization: University of Rochester

julie_ryan@urmc.rochester.edu

585-276-3862

Study Officials

• Julie Ryan, PhD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-02