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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02271581

Enrollment

Registered

2014-10-22

Start date

2014-10-31

Completion date

2019-04-19

Last updated

2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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)
Change in VeriStrat status	10 months	Percentage of patients who convert from poor to good

Countries

United States

Outcome results