Dietary Flaxseed in NSCLC

Study summary

This single arm Phase II trial will investigate the feasibility of dietary flaxseed (FS) supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung cancer (NSCLC). Subjects will ingest FS for a period of approximately 8 to 9 weeks during the course of radiation treatment. Study participation and surveillance will last approximately 6 months. Subject specimen collection will include: blood, urine, and buccal swabs at 5 time points.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedFlaxseed

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 8, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Abramson Cancer Center at Penn Medicine

Study sponsor

Study overview

What this study is about

Purpose: Supportive Care
Study type: Interventional
Phase: Phase 2
Sponsor: Abramson Cancer Center at Penn Medicine
Interventions being studied: Dietary Supplement: Flaxseed

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Male or female, ages 18 and older
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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 8, 2021. Always confirm current availability with the study team.

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