curcumin for the prevention of radiation-induced dermatitis in breast cancer patients

Conditions: Breast Cancer

Summary: ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. despite advances in medical technology, radiation therapy still causes severe early and late skin effects. radiation-induced dermatitis occurs in approximately 80% of patients. important consequences of radiation-induced dermatitis include impairment of the quality of a patient's life due to pain and premature interruption of radiation treatment, which in turn, may be impair good local control of disease. the biological pathways responsible for acute radiation-induced dermatitis remain unclear. currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness. the aim of this randomized, double-blind, placebo-controlled pilot study is to assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis during postoperative radiotherapy for breast cancer. we hypothesize that curcumin, a natural phenolic compound found in both turmeric and curry powders, can prevent or alleviate radiation-induced skin reactions in breast cancer patients receiving radiotherapy.

specifically, this clinical pilot study will develop data necessary to calculate a sample size for a larger study to be conducted through the national cancer institute (nci) community clinical oncology program (ccop) mechanism. specifically, this pilot project will investigate: 1) if curcumin can prevent or alleviate radiation-induced skin reactions in cancer patients receiving radiotherapy and 2) if skin pigmentation, as well as pain and psychophysiological factors, can predict the severity of radiation-induced dermatitis. potential future research studies may be conducted to identify the biological mechanisms involved in radiation-induced dermatitis and the radioprotective function of curcumin.

Eligibility criteria:
inclusion criteria: * female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy. * participants must be at least 21 years of age. * participants must not be pregnant. * participants can be from any racial or ethnic origin. * breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment. * participants with in situ breast cancer are eligible. * participants who are prescribed concurrent hormone treatment with radiation treatment are eligible. * participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 gy per session)or canadian (2.2-2.5 gy per session)irradiation fractionation. * a time period of three weeks must elapse after chemotherapy and surgery before beginning the study. * the total dose prescribed to the whole breast should be 50 gy or greater. * participants must be able to understand english and able to complete assessment forms (all assessment forms are in english). * participants must be able to swallow medication. * topical skin agents, e.g., aquaphor, cetaphil, or other emollients, are allowed either prn or prophylactically. * participant must give informed consent. exclusion criteria: * patients with bilateral breast cancer are not eligible. * patients who have had previous radiation therapy to the breast or chest are not eligible. * patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible. * patients who will be receiving treatment with herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (egfr) drugs, e.g. iressa (gefitinib), erbitux (cetuximab, c225), concurrently with their radiation therapy are not eligible. * patients cannot have had breast reconstructions, implants, and/or expanders. * patients with known radiosensitivity syndromes (e.g., ataxia-telangiectasia) are not eligible. * patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible. * patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to grade 2 change hemoglobin (i.e., 25% decrease from baseline); greater than or equal to grade 1 change in platelets (i.e., less than 75,000/mm3); greater than or equal to grade 2 change in pt and ptt(i.e., 1.5-2x upper level normal (uln)); greater than or equal to grade 1 change in ast, alt (i.e., greater than 2.5x uln); greater than or equal to grade 1 change in bilirubin (i.e., greater than 1.5x uln); greater than or equal to grade 1 change in creatinine (i.e., greater than 2x uln).

Keywords: radiation dermatitis in breast cancer patients