Philadelphia, Pennsylvania 19104


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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


NCT ID:

NCT02475330


Primary Contact:

Principal Investigator
Abigail Berman, MD
Abramson Cancer Center of the University of Pennsylvania

Abigail Berman, MD
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States

Abigail Berman, MD
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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