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

NCT ID: NCT00955942

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2018-06-30

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.

Conditions

Lung Cancer; Radiation Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

flaxseed

Intervention Type: DIETARY_SUPPLEMENT

Given orally

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

Interventions

flaxseed

Given orally

Intervention Type: DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC-07507

Identifier Type: -

Identifier Source: secondary_id

IRB# 806733

Identifier Type: -

Identifier Source: secondary_id

CDR0000644401

Identifier Type: -

Identifier Source: org_study_id