Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Curcumin C3 Complex
Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
干预措施: Curcumin C3 Complex (Drug)
Placebo
Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
干预措施: Placebo (Drug)
结局指标
主要结局
Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients
时间窗: 4-7 weeks (prescribed course of radiation)
The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.
次要结局
- Moist Desquamation at Radiation Treatment Site(4-7 weeks (prescribed course of radiation))
- Redness at Radiation Treatment Site(4-7 weeks (prescribed course of radiation))
- Pain at Radiation Treatment Site(4-7 weeks (prescribed course of radiation))
研究者
Julie Ryan
Assistant Professor
University of Rochester