955942
Last Update Posted: 2020-04-02
Recruiting has ended
All Genders accepted | 18 Years-120 Years |
48 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
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.
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 cancer.
- To collect toxicity and tolerability data on dietary FS supplementation during definitive chemoradiotherapy.
Secondary
- To validate urinary and serum markers of oxidative stress and FS lignan levels as surrogates of the bioavailability of FS in these patients.
- To determine if a dose response to daily ingestion of 20 g or 40 g of FS can be observed in plasma lignan levels and urinary markers of oxidative stress.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
- Arm II: Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
Blood and urine samples are collected periodically for biomarker studies.
After completion of study treatment, patients are followed up for 1 month.
Eligibility
Relevant conditions:
Lung Cancer
Radiation Toxicity
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov