Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
Conditions
Lung Cancer - Radiation Toxicity
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Radiation Injuries
Conditions: Keywords
radiation toxicity, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, stage IV non-small cell lung cancer
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Intervention
Name: flaxseed Type: Dietary Supplement
Name: placebo Type: Other
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers - 800-474-9892
Start Date
December 2007
Sponsors
University of Pennsylvania
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page