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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

INSYNC: Leo Jenkins Cancer Center (LJCC) - Symptom Management Service (SMS) Protocol -Phase II Trial Regarding The Effect Of Comprehensive Symptom Management On Inflammation And Survival In Metastatic Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271581
• Other study ID #: INSYNC
• Status: Completed
• Start date: October 2014
• Est. completion date: April 19, 2019

Study information

• Verified date: November 2020
• Source: Leo W. Jenkins Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Inflammation
• Lung Neoplasms

Locations

Country	Name	City	State
United States	Leo Jenkins Cancer Center	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Leo W. Jenkins Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival from diagnosis until death from any cause	Patients will be followed for 5 years after enrolling last patient
Secondary	Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)	Baseline versus 4 months; Baseline versus 10 months; 4 months versus 10 months	10 months
Secondary	Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups	VeriStrat "Good" and CRP "low" (<10 mg/L); VeriStrat "Good" and CRP "high" (>10 mg/L); VeriStrat "Poor" and CRP "low" (<10 mg/L); VeriStrat "Poor" and CRP "high" (>10 mg/L)	10 months
Secondary	Change in VeriStrat status	Percentage of patients who convert from "poor" to "good"	10 months