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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Terminated

CT.gov ID

NCT00955942

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

126

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Radiation Toxicity	Dietary Supplement: flaxseed Other: placebo	Phase 1

Detailed 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

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: flaxseed Given orally
Placebo Comparator: 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.	Other: placebo Given orally

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: flaxseed

Given orally

Placebo Comparator: 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.

Other: placebo

Given orally

Outcome Measures

Primary Outcome Measures

Feasibility of dietary flaxseed (FS) supplementation []
Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy []

Secondary Outcome Measures

Measures of biomarkers of oxidative stress []
Measures of serum levels of FS metabolites []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of non-small cell lung cancer
Locally advanced or metastatic disease
Requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy
Total planned radiation dose to gross disease 60-80 Gy

PATIENT CHARACTERISTICS:

No diagnosis of disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered metabolism or excretion of the study medication (e.g., history of major GI tract surgery, gastrectomy, gastrostomy, or bowel resection)
No history of chronic GI disorders (e.g., ulcerative colitis, regional enteritis, or GI bleeding)
No known hypersensitivity to flaxseed or any of its metabolites or to wheat products

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
See Patient Characteristics
More than 14 days since prior and no concurrent investigational drugs
More than 14 days since prior and no concurrent amifostine or Mucomyst (N-acetylcysteine)
No prior thoracic radiotherapy
No prior or other concurrent flaxseed, flax-containing products, soybeans, or soy-containing products
No other concurrent dietary supplements, such as herbals or botanicals
Vitamins or multivitamins, including calcium and vitamin D, are allowed