Dietary Flaxseed in NSCLC

Study Overview
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Brief Summary
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This single arm Phase II trial will investigate the feasibility of dietary flaxseed (FS) supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung cancer (NSCLC). Subjects will ingest FS for a period of approximately 8 to 9 weeks during the course of radiation treatment. Study participation and surveillance will last approximately 6 months. Subject specimen collection will include: blood, urine, and buccal swabs at 5 time points.

Official Title
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Phase II Trial of Flaxseed to Prevent Pneumonopathy After Chemoradiation for Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Dietary Supplement: Flaxseed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ages 18 and older Current diagnosis of non-small cell lung cancer (NSCLC) including patients who have metastatic disease requiring definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy. Able to provide written informed consent and comply with all study procedures Total planned radiation dose to gross disease 60-70 Gy. Exclusion Criteria: Current diagnosis of disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) Known hypersensitivity to flaxseed or any of its metabolites, or wheat products Taking or has taken an investigational drug within 14 days. Taking or has taken Amifostine or Mucomyst (N-acetylcysteine) within 14 days Current or prior use of flaxseed, flax-containing products, soybeans, or soy-containing products Current or prior use (limited to prior 14 days) of dietary supplements such as herbals or botanicals Prior thoracic and/or mediastinal radiation therapy

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement: Flaxseed<br> | Dietary Supplement: Flaxseed<br>* Whole grain flaxseed diet consisting of 40g flaxseed ingested per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Radiation-Induced Lung Injury | Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer. | 6 months | 
| Rates of Grade >3 Radiation Pneumonitis | Toxicity and tolerability data of dietary FS administration during chemoradiotherapy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of G-CSF |  | 6 months | 
| Concentration of GM-CSF |  | 6 months | 
| Concentration of IFN-α |  | 6 months | 
| Concentration of IFN-γ |  | 6 months | 
| Concentration of IL-1β |  | 6 months | 
| Concentration of IL-1RA |  | 6 months | 
| Concentration of IL-2 |  | 6 months | 
| Concentration of IL-2R |  | 6 months | 
| Concentration of IL-4 |  | 6 months | 
| Concentration of IL-5 |  | 6 months | 
| Concentration of IL-6 |  | 6 months | 
| Concentration of IL-7 |  | 6 months | 
| Concentration of IL-8 |  | 6 months | 
| Concentration of IL-10 |  | 6 months | 
| Concentration of IL-12 |  | 6 months | 
| Concentration of IL-13 |  | 6 months | 
| Concentration of IL-15 |  | 6 months | 
| Concentration of IL-17 |  | 6 months | 
| Concentration of TNF-α |  | 6 months | 
| Concentration of Eotaxin |  | 6 months | 
| Concentration of IP-10 |  | 6 months | 
| Concentration of MCP-1 |  | 6 months | 
| Concentration of MIG |  | 6 months | 
| Concentration of MIP-1α |  | 6 months | 
| Concentration of MIP-1ß |  | 6 months | 
| Concentration of RANTES |  | 6 months | 
| Concentration of EGF |  | 6 months | 
| Concentration of FGF-Basic |  | 6 months | 
| Concentration of HGF |  | 6 months | 
| Concentration of VEGF |  | 6 months |