Oral Curcumin for Radiation Dermatitis

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

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..

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Cancer Institute (NCI)
• Treatments: Curcumin

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