Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients
21 Years
N/A
Female
Radiation-induced Dermatitis
Trial Information
Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Outcome Measure:
To evaluate the degree to which curcumin can reduce radiation-induced skin reactions in breast cancer patients receiving radiotherapy.
Outcome Description:
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).
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Julie Ryan, PhD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Rochester
Authority:
United States: Food and Drug Administration
Study ID:
URCC 10054
NCT ID:
NCT01246973
Start Date:
February 2011
Completion Date:
August 2014
Related Keywords:
- Radiation-induced Dermatitis
- Oral Curcumin
- Radiation Dermatitis
- Breast Cancer Patients
- Breast Neoplasms
- Dermatitis
- Radiodermatitis
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