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

Abramson Cancer Center at Penn Medicine

Status and phase

Terminated

Phase 1

Conditions

Radiation Toxicity

Lung Cancer

Treatments

Other: placebo

Dietary Supplement: flaxseed

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00955942

CDR0000644401

IRB# 806733

UPCC-07507

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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