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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00955942
First received: August 7, 2009
Last updated: August 29, 2009
Last verified: August 2009
  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-Blind
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility of dietary flaxseed (FS) supplementation [ Designated as safety issue: No ]
  • Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measures of biomarkers of oxidative stress [ Designated as safety issue: No ]
  • Measures of serum levels of FS metabolites [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2007
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955942

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Ramesh Rengan, MD, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Ramesh Rengan, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00955942     History of Changes
Other Study ID Numbers: CDR0000644401, UPCC-03309, IRB# 806733
Study First Received: August 7, 2009
Last Updated: August 29, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Radiation Injuries
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 14, 2014