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

Phase 1TerminatedNCT00955942

Abramson Cancer Center at Penn Medicine48 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lung Cancer Radiation Toxicity

Interventions

flaxseedDIETARY_SUPPLEMENT

Given orally

placeboOTHER

Given orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Feasibility of dietary flaxseed (FS) supplementation

Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy

Secondary Outcomes

Measures of biomarkers of oxidative stress

Measures of serum levels of FS metabolites

Data from ClinicalTrials.gov

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