NCT02475330

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

3.3 years

First QC Date

June 16, 2015

Last Update Submit

June 4, 2021

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Rate of Radiation-Induced Lung Injury

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

    6 months

  • Rates of Grade >3 Radiation Pneumonitis

    Toxicity and tolerability data of dietary FS administration during chemoradiotherapy

    6 months

Secondary Outcomes (30)

  • Concentration of G-CSF

    6 months

  • Concentration of GM-CSF

    6 months

  • Concentration of IFN-α

    6 months

  • Concentration of IFN-γ

    6 months

  • Concentration of IL-1β

    6 months

  • +25 more secondary outcomes

Study Arms (1)

Dietary Supplement: Flaxseed

EXPERIMENTAL
Dietary Supplement: Flaxseed

Interventions

FlaxseedDIETARY_SUPPLEMENT

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

Dietary Supplement: Flaxseed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 34161146DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Abigail Berman, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 18, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations

US(1)