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

NCT00955942 | Terminated Phase 1 DMC

• 3 other identifiers: CDR0000644401UPCC-07507IRB# 806733
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of dietary flaxseed (FS) supplementation

• Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy

Secondary Outcomes (2)

• Measures of biomarkers of oxidative stress

• Measures of serum levels of FS metabolites

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

PLACEBO COMPARATOR

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

Interventions

flaxseed DIETARY_SUPPLEMENT

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Radiation Injuries; Carcinoma, Non-Small-Cell Lung

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Alexander Lin, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: December 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: June 1, 2018
• Last Updated: April 2, 2020

Record last verified: 2020-04

Locations

US (1)