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Dietary Flaxseed in NSCLC

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Terminated
CT.gov ID
NCT02475330
Collaborator
(none)
33
Enrollment
1
Location
1
Arm
39
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Flaxseed
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Primary Purpose:
Supportive Care
Official Title:
Phase II Trial of Flaxseed to Prevent Pneumonopathy After Chemoradiation for Lung Cancer
Actual Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dietary Supplement: Flaxseed

Dietary Supplement: Flaxseed
Whole grain flaxseed diet consisting of 40g flaxseed ingested per day

Outcome Measures

Primary Outcome Measures

  1. Rate of Radiation-Induced Lung Injury [6 months]

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

  2. Rates of Grade >3 Radiation Pneumonitis [6 months]

    Toxicity and tolerability data of dietary FS administration during chemoradiotherapy

Secondary Outcome Measures

  1. Concentration of G-CSF [6 months]

  2. Concentration of GM-CSF [6 months]

  3. Concentration of IFN-α [6 months]

  4. Concentration of IFN-γ [6 months]

  5. Concentration of IL-1β [6 months]

  6. Concentration of IL-1RA [6 months]

  7. Concentration of IL-2 [6 months]

  8. Concentration of IL-2R [6 months]

  9. Concentration of IL-4 [6 months]

  10. Concentration of IL-5 [6 months]

  11. Concentration of IL-6 [6 months]

  12. Concentration of IL-7 [6 months]

  13. Concentration of IL-8 [6 months]

  14. Concentration of IL-10 [6 months]

  15. Concentration of IL-12 [6 months]

  16. Concentration of IL-13 [6 months]

  17. Concentration of IL-15 [6 months]

  18. Concentration of IL-17 [6 months]

  19. Concentration of TNF-α [6 months]

  20. Concentration of Eotaxin [6 months]

  21. Concentration of IP-10 [6 months]

  22. Concentration of MCP-1 [6 months]

  23. Concentration of MIG [6 months]

  24. Concentration of MIP-1α [6 months]

  25. Concentration of MIP-1ß [6 months]

  26. Concentration of RANTES [6 months]

  27. Concentration of EGF [6 months]

  28. Concentration of FGF-Basic [6 months]

  29. Concentration of HGF [6 months]

  30. Concentration of VEGF [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Abigail Berman, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02475330
Other Study ID Numbers:
  • UPCC 28514
First Posted:
Jun 18, 2015
Last Update Posted:
Jun 8, 2021
Last Verified:
Jun 1, 2021
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Jun 8, 2021