Clinical trial NCT00955942: Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
Official title: A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-08-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of dietary flaxseed (FS) supplementation
measure: Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy
Secondary outcomes:
measure: Measures of biomarkers of oxidative stress
measure: Measures of serum levels of FS metabolites
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Alexander Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: