Flaxseed in Preventing Pneumonopathy after Radiotherapy in Patients with Metastatic Non-small Cell Lung Cancer

Status: Active

Description

This phase II trial studies how well flaxseed works in preventing pneumonopathy after radiotherapy in patients with non-small cell lung cancer that has spread to other places in the body. Flaxseed contains antioxidants that can help prevent harmful chemical reactions in the body when oxygen is combined with other substances. Using flaxseed in a patient's diet may be helpful in reducing risk of damage to the lungs after radiotherapy.

Eligibility Criteria

Inclusion Criteria

  • Current diagnosis of non-small cell lung cancer (NSCLC) including patients who have metastatic disease requiring definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy.
  • Able to provide written informed consent and comply with all study procedures.
  • Total planned radiation dose to gross disease 60-70 Gy.

Exclusion Criteria

  • Current diagnosis of disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding).
  • Known hypersensitivity to flaxseed or any of its metabolites, or wheat products.
  • Taking or has taken an investigational drug within 14 days.
  • Taking or has taken Amifostine or Mucomyst (N-acetylcysteine) within 14 days.
  • Current or prior use of flaxseed, flax-containing products, soybeans, or soy-containing products.
  • Current or prior use (limited to prior 14 days) of dietary supplements such as herbals or botanicals.
  • Prior thoracic and/or mediastinal radiation therapy.

Locations & Contacts

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Abigail T. Berman
Phone: 215-662-2989

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Determine in a phase II trial whether flaxseed (FS) supplementation decreases the risk of radiation-induced lung injury (RILI) in patients receiving definitive chemoradiotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), and to collect additional toxicity and tolerability data from FS administration in this population.

SECONDARY OBJECTIVES:

I. Determine how FS modulates the markers of inflammation and oxidative damage.

OUTLINE:

Patients receive flaxseed orally (PO) daily starting 1 week prior to radotherapy (XRT) and over 7-8 weeks during XRT.

After completion of study, patients are followed up at 1 and 6 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Prevention

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Abigail T. Berman

Trial IDs

Primary ID UPCC 28514
Secondary IDs NCI-2015-01010
Clinicaltrials.gov ID NCT02475330