Dietary Flaxseed in NSCLC
Stopped early · Phase 2
Conditions studied: Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT02475330
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 33
- Starts
- 2015-05-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2021-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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