Status:
COMPLETED
Oral Curcumin for Radiation Dermatitis
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Radiation-induced Dermatitis
Eligibility:
FEMALE
21-120 years
Phase:
PHASE2
PHASE3
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 c...
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 medica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
686 Patients enrolled
Trial Details
Trial ID
NCT01246973
Start Date
February 1 2011
End Date
January 1 2015
Last Update
March 7 2016
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