Oral Curcumin for Radiation Dermatitis

University of Rochester

Status and phase

Completed

Phase 3

Phase 2

Conditions

Radiation-induced Dermatitis

Treatments

Drug: Curcumin

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01246973

URCC 09005 (Other Identifier)

U10CA037420 (U.S. NIH Grant/Contract)

URCC 10054 (Other Identifier)

Details and patient eligibility

About

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..

Full 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 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.

Enrollment

686 patients

Sex

Female

Ages

21 to 120 years old

Volunteers

No Healthy Volunteers

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