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Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955942
First Posted: August 10, 2009
Last Update Posted: February 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose

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 Intervention Phase
Lung Cancer Radiation Toxicity Dietary Supplement: flaxseed Other: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

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

Enrollment: 48
Study Start Date: December 2007
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given orally
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.
Other: placebo
Given orally

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alexander Lin, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00955942     History of Changes
Other Study ID Numbers: CDR0000644401
UPCC-03309
IRB# 806733
First Submitted: August 7, 2009
First Posted: August 10, 2009
Last Update Posted: February 10, 2016
Last Verified: February 2016

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Radiation Injuries
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Wounds and Injuries