Dietary Flaxseed in NSCLC | NCT02475330

Studies
Dietary Flaxseed in NSCLC

NCT02475330

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Terminated

Last Update Posted

Jun 8, 2021Actual

Enrollment

33Actual

Phase

Phase 2

Conditions

Lung Cancer

Interventions

Flaxseed

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of patient compliance

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jun 17, 2015

First Posted Date

Jun 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2021

Last Update Posted Date

Jun 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dietary Supplement: Flaxseed	Experimental		Dietary Supplement: Flaxseed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flaxseed	Dietary Supplement	Whole grain flaxseed diet consisting of 40g flaxseed ingested per day	Dietary Supplement: Flaxseed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Concentration of G-CSF		6 months
Concentration of GM-CSF		6 months
Concentration of IFN-α

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abigail Berman, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34161146	Derived	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.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D005224	Fats, Unsaturated
D005223	Fats
D008055	Lipids
D010938	Plant Oils
D009821