Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung … (NCT00955942) | Clinical Trial Compass
TerminatedPhase 1
Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
Stopped: Insufficient enrollment
United States48 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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
What they're measuring
1
Feasibility of dietary flaxseed (FS) supplementation
2
Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy