Back to resultsFlaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
Primary Purpose
Lung Cancer, Radiation Toxicity
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
flaxseed
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring radiation toxicity, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm I
Arm II
Arm Description
Patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
Outcomes
Primary Outcome Measures
Feasibility of dietary flaxseed (FS) supplementation
Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
Secondary Outcome Measures
Measures of biomarkers of oxidative stress
Measures of serum levels of FS metabolites
Full Information
NCT ID
NCT00955942
First Posted
August 7, 2009
Last Updated
April 1, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00955942
Brief Title
Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Radiation Toxicity
Keywords
radiation toxicity, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, stage IV non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
flaxseed
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Feasibility of dietary flaxseed (FS) supplementation
Title
Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
Secondary Outcome Measure Information:
Title
Measures of biomarkers of oxidative stress
Title
Measures of serum levels of FS metabolites
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Lin, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
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