NCT02475330终止2 期
Phase II Trial of Flaxseed to Prevent Pneumonopathy After Chemoradiation for Lung Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Rate of Radiation-Induced Lung Injury
研究概览
简要总结
This single arm Phase II trial will investigate the feasibility of dietary flaxseed (FS) supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung cancer (NSCLC). Subjects will ingest FS for a period of approximately 8 to 9 weeks during the course of radiation treatment. Study participation and surveillance will last approximately 6 months. Subject specimen collection will include: blood, urine, and buccal swabs at 5 time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ages 18 and older
- •Current diagnosis of non-small cell lung cancer (NSCLC) including patients who have metastatic disease requiring definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy.
- •Able to provide written informed consent and comply with all study procedures
- •Total planned radiation dose to gross disease 60-70 Gy.
排除标准
- •Current diagnosis of disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding)
- •Known hypersensitivity to flaxseed or any of its metabolites, or wheat products
- •Taking or has taken an investigational drug within 14 days.
- •Taking or has taken Amifostine or Mucomyst (N-acetylcysteine) within 14 days
- •Current or prior use of flaxseed, flax-containing products, soybeans, or soy-containing products
- •Current or prior use (limited to prior 14 days) of dietary supplements such as herbals or botanicals
- •Prior thoracic and/or mediastinal radiation therapy
结局指标
主要结局
Rate of Radiation-Induced Lung Injury
时间窗: 6 months
Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer.
Rates of Grade >3 Radiation Pneumonitis
时间窗: 6 months
Toxicity and tolerability data of dietary FS administration during chemoradiotherapy
次要结局
- Concentration of IL-2(6 months)
- Concentration of IL-7(6 months)
- Concentration of IL-8(6 months)
- Concentration of IL-13(6 months)
- Concentration of IL-15(6 months)
- Concentration of TNF-α(6 months)
- Concentration of G-CSF(6 months)
- Concentration of IL-12(6 months)
- Concentration of MIP-1α(6 months)
- Concentration of MCP-1(6 months)
- Concentration of MIG(6 months)
- Concentration of IL-4(6 months)
- Concentration of IL-6(6 months)
- Concentration of IFN-γ(6 months)
- Concentration of IFN-α(6 months)
- Concentration of IL-1RA(6 months)
- Concentration of IL-10(6 months)
- Concentration of IL-5(6 months)
- Concentration of RANTES(6 months)
- Concentration of HGF(6 months)
- Concentration of Eotaxin(6 months)
- Concentration of IP-10(6 months)
- Concentration of EGF(6 months)
- Concentration of FGF-Basic(6 months)
- Concentration of VEGF(6 months)
- Concentration of GM-CSF(6 months)
- Concentration of IL-1β(6 months)
- Concentration of IL-2R(6 months)
- Concentration of IL-17(6 months)
- Concentration of MIP-1ß(6 months)
研究者
研究点 (2)
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