Overview

This trial is active, not recruiting.

Conditions lung cancer, radiation toxicity
Treatments flaxseed, placebo
Phase phase 1
Sponsor Abramson Cancer Center of the University of Pennsylvania
Collaborator National Cancer Institute (NCI)
Start date December 2007
End date July 2012
Trial size 48 participants
Trial identifier NCT00955942, CDR0000644401, IRB# 806733, UPCC-03309

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking double-blind
Primary purpose treatment
Arm
(Experimental)
Patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
flaxseed
Given orally
(Placebo Comparator)
Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
placebo
Given orally

Primary Outcomes

Measure
Feasibility of dietary flaxseed (FS) supplementation
time frame:
Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
time frame:

Secondary Outcomes

Measure
Measures of biomarkers of oxidative stress
time frame:
Measures of serum levels of FS metabolites
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy
Principal investigator Alexander Lin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.