Clinical trial NCT02475330: Dietary Flaxseed in NSCLC
Official title: Phase II Trial of Flaxseed to Prevent Pneumonopathy After Chemoradiation for Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Rate of Radiation-Induced Lung Injury
timeFrame: 6 months
measure: Rates of Grade >3 Radiation Pneumonitis
timeFrame: 6 months
Secondary outcomes:
measure: Concentration of G-CSF
timeFrame: 6 months
measure: Concentration of GM-CSF
timeFrame: 6 months
measure: Concentration of IFN-α
timeFrame: 6 months
measure: Concentration of IFN-γ
timeFrame: 6 months
measure: Concentration of IL-1β
timeFrame: 6 months
measure: Concentration of IL-1RA
timeFrame: 6 months
measure: Concentration of IL-2
timeFrame: 6 months
measure: Concentration of IL-2R
timeFrame: 6 months
measure: Concentration of IL-4
timeFrame: 6 months
measure: Concentration of IL-5
timeFrame: 6 months
measure: Concentration of IL-6
timeFrame: 6 months
measure: Concentration of IL-7
timeFrame: 6 months
measure: Concentration of IL-8
timeFrame: 6 months
measure: Concentration of IL-10
timeFrame: 6 months
measure: Concentration of IL-12
timeFrame: 6 months
measure: Concentration of IL-13
timeFrame: 6 months
measure: Concentration of IL-15
timeFrame: 6 months
measure: Concentration of IL-17
timeFrame: 6 months
measure: Concentration of TNF-α
timeFrame: 6 months
measure: Concentration of Eotaxin
timeFrame: 6 months
measure: Concentration of IP-10
timeFrame: 6 months
measure: Concentration of MCP-1
timeFrame: 6 months
measure: Concentration of MIG
timeFrame: 6 months
measure: Concentration of MIP-1α
timeFrame: 6 months
measure: Concentration of MIP-1ß
timeFrame: 6 months
measure: Concentration of RANTES
timeFrame: 6 months
measure: Concentration of EGF
timeFrame: 6 months
measure: Concentration of FGF-Basic
timeFrame: 6 months
measure: Concentration of HGF
timeFrame: 6 months
measure: Concentration of VEGF
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Abigail Berman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.