Dietary Flaxseed in NSCLC
- Conditions
- Lung Cancer
- Interventions
- Dietary Supplement: Flaxseed
- Registration Number
- NCT02475330
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dietary Supplement: Flaxseed Flaxseed -
- Primary Outcome Measures
Name Time Method Rate of Radiation-Induced Lung Injury 6 months Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer.
Rates of Grade >3 Radiation Pneumonitis 6 months Toxicity and tolerability data of dietary FS administration during chemoradiotherapy
- Secondary Outcome Measures
Name Time Method Concentration of IL-4 6 months Concentration of IL-6 6 months Concentration of IL-7 6 months Concentration of IL-8 6 months Concentration of IL-13 6 months Concentration of IL-15 6 months Concentration of TNF-α 6 months Concentration of IL-2 6 months Concentration of IFN-α 6 months Concentration of IFN-γ 6 months Concentration of IL-1RA 6 months Concentration of IL-10 6 months Concentration of MIP-1α 6 months Concentration of IL-5 6 months Concentration of RANTES 6 months Concentration of HGF 6 months Concentration of Eotaxin 6 months Concentration of IP-10 6 months Concentration of EGF 6 months Concentration of FGF-Basic 6 months Concentration of VEGF 6 months Concentration of GM-CSF 6 months Concentration of IL-1β 6 months Concentration of IL-2R 6 months Concentration of IL-17 6 months Concentration of MIP-1ß 6 months Concentration of G-CSF 6 months Concentration of IL-12 6 months Concentration of MCP-1 6 months Concentration of MIG 6 months
Trial Locations
- Locations (1)
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States