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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-04-19

Brief Summary

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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

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Conditions

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Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geoffrey Stroud, PharmD, BCOP, CPP

Role: PRINCIPAL_INVESTIGATOR

Brody School of Medicine at ECU

Locations

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Leo Jenkins Cancer Center

Greenville, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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INSYNC

Identifier Type: -

Identifier Source: org_study_id