Status:
TERMINATED
Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Radiation Toxicity
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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 ...
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00955942
Start Date
December 1 2007
End Date
June 1 2018
Last Update
April 2 2020
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283