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

Lung Cancer Clinical Trial

Official title:

A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00955942
• Other study ID #: CDR0000644401
• Secondary ID: UPCC-07507IRB# 8
• Status: Terminated
• Phase: Phase 1
• Start date: December 2007
• Est. completion date: June 2018

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: June 2018
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Radiation Toxicity

Intervention

Dietary Supplement:
• flaxseed
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of dietary flaxseed (FS) supplementation
Primary	Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
Secondary	Measures of biomarkers of oxidative stress
Secondary	Measures of serum levels of FS metabolites