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.
- 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
- Able to provide written informed consent and comply with all study procedures
- Total planned radiation dose to gross disease 60-70 Gy.
- 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
- Current or prior use (limited to prior 14 days) of dietary supplements such as
herbals or botanicals
- Prior thoracic and/or mediastinal radiation therapy