Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00955942|
Recruitment Status : Unknown
Verified February 2016 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was: Active, not recruiting
First Posted : August 10, 2009
Last Update Posted : February 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Radiation Toxicity||Dietary Supplement: flaxseed Other: placebo||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Official Title:||A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||July 2012|
Experimental: 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.
Dietary Supplement: flaxseed
Placebo Comparator: 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.
- Feasibility of dietary flaxseed (FS) supplementation
- Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
- Measures of biomarkers of oxidative stress
- Measures of serum levels of FS metabolites
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955942
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Alexander Lin, MD||Abramson Cancer Center of the University of Pennsylvania|