A Phase 1 interventional study of flaxseed and placebo in Lung Cancer and Radiation Toxicity, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 1, Interventional, and Treatment
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
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Blood and urine samples are collected periodically for biomarker studies.
After completion of study treatment, patients are followed up for 1 month.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
Requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No other concurrent dietary supplements, such as herbals or botanicals
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
Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
Other: placebo
Given orally
Given orally
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
The record gives a start of Dec 2007, a primary completion of Jul 2012 and a completion of Jun 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Flaxseed
Abramson Cancer Center at Penn Medicine →