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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer, Radiation Toxicity

Intervention / Treatment
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* Dietary Supplement: flaxseed
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Given orally<br>|
| Placebo Comparator: Arm II<br>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<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of dietary flaxseed (FS) supplementation |  |  | 
| Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of biomarkers of oxidative stress |  |  | 
| Measures of serum levels of FS metabolites |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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