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Oral Curcumin for Radiation Dermatitis

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Julie Ryan, University of Rochester
ClinicalTrials.gov Identifier:
NCT01246973
First received: November 22, 2010
Last updated: February 8, 2016
Last verified: February 2016

November 22, 2010
February 8, 2016
February 2011
November 2014   (final data collection date for primary outcome measure)
Mean Radiation Dermatitis Severity Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
To evaluate the degree to which curcumin can reduce radiation-induced skin reactions in breast cancer patients receiving radiotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The outcome measures will be the severity of radiation dermatitis, using the RDS scale, 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).
Complete list of historical versions of study NCT01246973 on ClinicalTrials.gov Archive Site
Percentage of Subjects With Moist Desquamation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.
How curcumin can prevent or decrease the incidence of moist desquamation, redness and pain at treatment site [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary outcome measures will be moist desquamation (i.e., RDS 3.5 or higher), redness at treatment site (EI), and pain at treatment site (SF-MPQ-2), taking into consideration the degree to which curcumin can decrease the incidence of moist desquamation, as well as the number of sites of moist desquamation, and to decrease the number of treatment interruptions due to skin reactions.
Not Provided
Not Provided
 
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..
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Radiation-induced Dermatitis
  • 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
  • Drug: Placebo
    4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
  • Experimental: curcumin
    4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
    Intervention: Drug: Curcumin
  • Placebo Comparator: Placebo
    4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
686
January 2015
November 2014   (final data collection date for primary outcome measure)

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
Female
21 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01246973
URCC 10054, URCC 09005, U10CA037420, URCC 10054
Yes
Not Provided
Not Provided
Julie Ryan, University of Rochester
University of Rochester
National Cancer Institute (NCI)
Principal Investigator: Julie Ryan, PhD, MPH University of Rochester
University of Rochester
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP