A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy
OBJECTIVES:
Primary
- To assess the feasibility of dietary flaxseed (FS) supplementation in patients
undergoing definitive chemoradiotherapy for locally advanced or metastatic non-small
cell lung cancer.
- To collect toxicity and tolerability data on dietary FS supplementation during
definitive chemoradiotherapy.
Secondary
- To validate urinary and serum markers of oxidative stress and FS lignan levels as
surrogates of the bioavailability of FS in these patients.
- To determine if a dose response to daily ingestion of 20 g or 40 g of FS can be
observed in plasma lignan levels and urinary markers of oxidative stress.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients consume flaxseed muffins once or twice daily beginning on the first day
of radiotherapy and continuing for up to 9-10 weeks.
- Arm II: Patients consume placebo muffins once or twice daily beginning on the first day
of radiotherapy and continuing for up to 9-10 weeks.
Blood and urine samples are collected periodically for biomarker studies.
After completion of study treatment, patients are followed up for 1 month.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Feasibility of dietary flaxseed (FS) supplementation
No
Ramesh Rengan, MD, PhD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
Unspecified
CDR0000644401
NCT00955942
December 2007
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |