Flaxseed Supplement in Treating Patients With Locally Advanced or

Status Terminated

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Flaxseed may help protect normal cells from the side effects of radiation therapy.

PURPOSE: This randomized phase I trial is studying the side effects of flaxseed supplement in treating patients with locally advanced or metastatic non-small cell lung cancer undergoing chemotherapy and radiation therapy.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00955942
Study type	Interventional
Source	Abramson Cancer Center of the University of Pennsylvania
Contact
Status	Terminated
Phase	Phase 1
Start date	December 2007
Completion date	June 2018

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Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms