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TerminatedNCT02475330Updated Jun 8, 2021

Dietary Flaxseed in NSCLC

A Phase 2 interventional study of Flaxseed in Lung Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by Abramson Cancer Center at Penn Medicine · Phase 2, Interventional, and Supportive care

Why this study was terminated
Lack of patient compliance
Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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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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Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion 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.

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Dietary Supplement: Flaxseed

    Dietary Supplement: Flaxseed

Interventions

  • Dietary supplementFlaxseed

    Whole grain flaxseed diet consisting of 40g flaxseed ingested per day

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What researchers measure

Primary outcomes

  1. Rate of Radiation-Induced Lung Injury

    Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer.

    Time frame: 6 months

  2. Rates of Grade >3 Radiation Pneumonitis

    Toxicity and tolerability data of dietary FS administration during chemoradiotherapy

    Time frame: 6 months

Secondary outcomes

  1. Concentration of G-CSF

    Time frame: 6 months

  2. Concentration of GM-CSF

    Time frame: 6 months

  3. Concentration of IFN-α

    Time frame: 6 months

  4. Concentration of IFN-γ

    Time frame: 6 months

  5. Concentration of IL-1β

    Time frame: 6 months

  6. Concentration of IL-1RA

    Time frame: 6 months

  7. Concentration of IL-2

    Time frame: 6 months

  8. Concentration of IL-2R

    Time frame: 6 months

  9. Concentration of IL-4

    Time frame: 6 months

  10. Concentration of IL-5

    Time frame: 6 months

  11. Concentration of IL-6

    Time frame: 6 months

  12. Concentration of IL-7

    Time frame: 6 months

  13. Concentration of IL-8

    Time frame: 6 months

  14. Concentration of IL-10

    Time frame: 6 months

  15. Concentration of IL-12

    Time frame: 6 months

  16. Concentration of IL-13

    Time frame: 6 months

  17. Concentration of IL-15

    Time frame: 6 months

  18. Concentration of IL-17

    Time frame: 6 months

  19. Concentration of TNF-α

    Time frame: 6 months

  20. Concentration of Eotaxin

    Time frame: 6 months

  21. Concentration of IP-10

    Time frame: 6 months

  22. Concentration of MCP-1

    Time frame: 6 months

  23. Concentration of MIG

    Time frame: 6 months

  24. Concentration of MIP-1α

    Time frame: 6 months

  25. Concentration of MIP-1ß

    Time frame: 6 months

  26. Concentration of RANTES

    Time frame: 6 months

  27. Concentration of EGF

    Time frame: 6 months

  28. Concentration of FGF-Basic

    Time frame: 6 months

  29. Concentration of HGF

    Time frame: 6 months

  30. Concentration of VEGF

    Time frame: 6 months

07

Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • Lim TL, Pietrofesa RA, Arguiri E, Koumenis C, Feigenberg S, Simone CB 2nd, Rengan R, Cengel K, Levin WP, Christofidou-Solomidou M, Berman AT. Phase II Trial of Flaxseed to Prevent Acute Complications After Chemoradiation for Lung Cancer. J Altern Complement Med. 2021 Oct;27(10):824-831. doi: 10.1089/acm.2020.0542. Epub 2021 Jun 23. PubMed 34161146 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 27, 2017

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02475330
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Jun 18, 2015
Start date
May 2015
Primary completion
Aug 2018
Completion
Aug 2018
Last update
Jun 8, 2021

Study contacts

Abigail Berman, MD
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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