A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Flaxseed may help protect normal cells from the side effects of radiation therapy.
PURPOSE: This randomized phase I trial is studying the side effects of flaxseed supplement in treating patients with locally advanced or metastatic non-small cell lung cancer undergoing chemotherapy and radiation therapy.
详细描述
OBJECTIVES:
Primary
- To assess the feasibility of dietary flaxseed (FS) supplementation in patients undergoing definitive chemoradiotherapy for locally advanced or metastatic non-small cell lung cancer.
- To collect toxicity and tolerability data on dietary FS supplementation during definitive chemoradiotherapy.
Secondary
- To validate urinary and serum markers of oxidative stress and FS lignan levels as surrogates of the bioavailability of FS in these patients.
- To determine if a dose response to daily ingestion of 20 g or 40 g of FS can be observed in plasma lignan levels and urinary markers of oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of non-small cell lung cancer
- •Locally advanced or metastatic disease
- •Requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy
- •Total planned radiation dose to gross disease 60-80 Gy
- •PATIENT CHARACTERISTICS:
- •No diagnosis of disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered metabolism or excretion of the study medication (e.g., history of major GI tract surgery, gastrectomy, gastrostomy, or bowel resection)
- •No history of chronic GI disorders (e.g., ulcerative colitis, regional enteritis, or GI bleeding)
- •No known hypersensitivity to flaxseed or any of its metabolites or to wheat products
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •See Patient Characteristics
- •More than 14 days since prior and no concurrent investigational drugs
- •More than 14 days since prior and no concurrent amifostine or Mucomyst (N-acetylcysteine)
- •No prior thoracic radiotherapy
- •No prior or other concurrent flaxseed, flax-containing products, soybeans, or soy-containing products
- •No other concurrent dietary supplements, such as herbals or botanicals
- •Vitamins or multivitamins, including calcium and vitamin D, are allowed
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
干预措施: flaxseed (Dietary Supplement)
Arm II
Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
干预措施: placebo (Other)
结局指标
主要结局
Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
Feasibility of dietary flaxseed (FS) supplementation
次要结局
- Measures of biomarkers of oxidative stress
- Measures of serum levels of FS metabolites