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Dietary Flaxseed in NSCLC

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Flaxseed
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary Supplement: Flaxseed

Arm Description

Outcomes

Primary Outcome Measures

Rate of Radiation-Induced Lung Injury
Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer.
Rates of Grade >3 Radiation Pneumonitis
Toxicity and tolerability data of dietary FS administration during chemoradiotherapy

Secondary Outcome Measures

Concentration of G-CSF
Concentration of GM-CSF
Concentration of IFN-α
Concentration of IFN-γ
Concentration of IL-1β
Concentration of IL-1RA
Concentration of IL-2
Concentration of IL-2R
Concentration of IL-4
Concentration of IL-5
Concentration of IL-6
Concentration of IL-7
Concentration of IL-8
Concentration of IL-10
Concentration of IL-12
Concentration of IL-13
Concentration of IL-15
Concentration of IL-17
Concentration of TNF-α
Concentration of Eotaxin
Concentration of IP-10
Concentration of MCP-1
Concentration of MIG
Concentration of MIP-1α
Concentration of MIP-1ß
Concentration of RANTES
Concentration of EGF
Concentration of FGF-Basic
Concentration of HGF
Concentration of VEGF

Full Information

First Posted
June 16, 2015
Last Updated
June 4, 2021
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02475330
Brief Title
Dietary Flaxseed in NSCLC
Official Title
Phase II Trial of Flaxseed to Prevent Pneumonopathy After Chemoradiation for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient compliance
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement: Flaxseed
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Flaxseed
Intervention Description
Whole grain flaxseed diet consisting of 40g flaxseed ingested per day
Primary Outcome Measure Information:
Title
Rate of Radiation-Induced Lung Injury
Description
Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer.
Time Frame
6 months
Title
Rates of Grade >3 Radiation Pneumonitis
Description
Toxicity and tolerability data of dietary FS administration during chemoradiotherapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Concentration of G-CSF
Time Frame
6 months
Title
Concentration of GM-CSF
Time Frame
6 months
Title
Concentration of IFN-α
Time Frame
6 months
Title
Concentration of IFN-γ
Time Frame
6 months
Title
Concentration of IL-1β
Time Frame
6 months
Title
Concentration of IL-1RA
Time Frame
6 months
Title
Concentration of IL-2
Time Frame
6 months
Title
Concentration of IL-2R
Time Frame
6 months
Title
Concentration of IL-4
Time Frame
6 months
Title
Concentration of IL-5
Time Frame
6 months
Title
Concentration of IL-6
Time Frame
6 months
Title
Concentration of IL-7
Time Frame
6 months
Title
Concentration of IL-8
Time Frame
6 months
Title
Concentration of IL-10
Time Frame
6 months
Title
Concentration of IL-12
Time Frame
6 months
Title
Concentration of IL-13
Time Frame
6 months
Title
Concentration of IL-15
Time Frame
6 months
Title
Concentration of IL-17
Time Frame
6 months
Title
Concentration of TNF-α
Time Frame
6 months
Title
Concentration of Eotaxin
Time Frame
6 months
Title
Concentration of IP-10
Time Frame
6 months
Title
Concentration of MCP-1
Time Frame
6 months
Title
Concentration of MIG
Time Frame
6 months
Title
Concentration of MIP-1α
Time Frame
6 months
Title
Concentration of MIP-1ß
Time Frame
6 months
Title
Concentration of RANTES
Time Frame
6 months
Title
Concentration of EGF
Time Frame
6 months
Title
Concentration of FGF-Basic
Time Frame
6 months
Title
Concentration of HGF
Time Frame
6 months
Title
Concentration of VEGF
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abigail Berman, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34161146
Citation
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.
Results Reference
derived

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Dietary Flaxseed in NSCLC

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