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

November 3, 2020 updated by: Leo W. Jenkins Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Leo Jenkins Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with metastatic (stage IV) non-small cell lung cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leo W. Jenkins Cancer Center

Investigators

  • Principal Investigator: Geoffrey Stroud, PharmD, BCOP, CPP, Brody School of Medicine at ECU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 19, 2019

Study Completion (Actual)

April 19, 2019

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSYNC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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