Effect of Symptom Management on Inflammation and Survival in Metastatic Lung Cancer

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

• Registration Number: NCT02271581
• Lead Sponsor: Leo W. Jenkins Cancer Center

Brief Summary

There is a growing body of evidence that implicates inflammation as a mechanism of disease progression and reduced survival in patients with advanced cancer. Elevated c-reactive protein levels have been shown to be associated with reduced performance status, specific cancer related symptoms and reduced overall survival. C-reactive protein levels are a surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer recurrence. VeriStrat® is a multivariate test which measures protein expression related to a host/tumor interaction mediated by inflammation. The investigators hope to examine the relationship between quality of life outcomes per FACT-L survey and correlate them with changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study is that the remarkable survival benefit in the Temel study is mediated by reduced inflammation with improvement of symptom control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-30
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Confirmed diagnosis of stage IV non-small cell lung cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Able to read and respond to questions in English

Exclusion Criteria

• Small Cell Lung Cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	Patients will be followed for 5 years after enrolling last patient	Overall survival from diagnosis until death from any cause

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)	10 months	1. Baseline versus 4 months; 2. Baseline versus 10 months; 3. 4 months versus 10 months
Change in VeriStrat status	10 months	Percentage of patients who convert from "poor" to "good"
Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups	10 months	1. VeriStrat "Good" and CRP "low" (\<10 mg/L); 2. VeriStrat "Good" and CRP "high" (\>10 mg/L); 3. VeriStrat "Poor" and CRP "low" (\<10 mg/L); 4. VeriStrat "Poor" and CRP "high" (\>10 mg/L)

Trial Locations

Locations (1)

Leo Jenkins Cancer Center; 🇺🇸 Greenville, North Carolina, United States