Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
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.
Checked against the public recordLast updated Apr 2, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Interventions being studied
- Dietary Supplement: flaxseed; Other: placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 2, 2020. Always confirm current availability with the study team.