Dietary Flaxseed in NSCLC

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Flaxseed to Prevent Pneumonopathy After Chemoradiation for Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02475330
• Other study ID #: UPCC 28514
• Status: Terminated
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: August 2018

Study information

• Verified date: June 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rates of Grade >3 Radiation Pneumonitis	Toxicity and tolerability data of dietary FS administration during chemoradiotherapy	6 months
Secondary	Concentration of G-CSF		6 months
Secondary	Concentration of GM-CSF		6 months
Secondary	Concentration of IFN-a		6 months
Secondary	Concentration of IFN-?		6 months
Secondary	Concentration of IL-1ß		6 months
Secondary	Concentration of IL-1RA		6 months
Secondary	Concentration of IL-2		6 months
Secondary	Concentration of IL-2R		6 months
Secondary	Concentration of IL-4		6 months
Secondary	Concentration of IL-5		6 months
Secondary	Concentration of IL-6		6 months
Secondary	Concentration of IL-7		6 months
Secondary	Concentration of IL-8		6 months
Secondary	Concentration of IL-10		6 months
Secondary	Concentration of IL-12		6 months
Secondary	Concentration of IL-13		6 months
Secondary	Concentration of IL-15		6 months
Secondary	Concentration of IL-17		6 months
Secondary	Concentration of TNF-a		6 months
Secondary	Concentration of Eotaxin		6 months
Secondary	Concentration of IP-10		6 months
Secondary	Concentration of MCP-1		6 months
Secondary	Concentration of MIG		6 months
Secondary	Concentration of MIP-1a		6 months
Secondary	Concentration of MIP-1ß		6 months
Secondary	Concentration of RANTES		6 months
Secondary	Concentration of EGF		6 months
Secondary	Concentration of FGF-Basic		6 months
Secondary	Concentration of HGF		6 months
Secondary	Concentration of VEGF		6 months