Dietary Flaxseed in NSCLC

Abramson Cancer Center at Penn Medicine

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Dietary Supplement: Flaxseed

Study type

Interventional

Funder types

Other

Identifiers

NCT02475330

UPCC 28514

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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