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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Radiation Toxicity

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Feasibility of dietary flaxseed (FS) supplementation

Safety Issue:

No

Principal Investigator

Ramesh Rengan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

Unspecified

Study ID:

CDR0000644401

NCT ID:

NCT00955942

Start Date:

December 2007

Completion Date:

Related Keywords:

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

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283