Lung Cancer, Radiation Toxicity
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTflaxseed
Given orally
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of dietary flaxseed (FS) supplementation | — |
| Toxicity and tolerability of dietary FS supplementation during chemoradiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Measures of biomarkers of oxidative stress | — |
| Measures of serum levels of FS metabolites | — |
Countries
United States
Outcome results
None listed