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TerminatedPhase 1NCT00955942
Official study title

Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedflaxseed and placebo

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 2, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

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

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Abramson Cancer Center at Penn Medicine
Interventions being studied
Dietary Supplement: flaxseed; Other: placebo
02
Explore related studies

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)→
Disease setting
Locally advanced→Metastatic or stage IV→
Treatment approach
Chemotherapy→Radiation therapy→
03
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
  • 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

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

04
Study sites

U.S. locations

  • Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 2, 2020. Always confirm current availability with the study team.

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