Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Patients will be followed for 5 years after enrolling last patient
- description
- Overall survival from diagnosis until death from any cause
Secondary outcomes (3)
- measure
- Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)
- timeFrame
- 10 months
- description
- 1. Baseline versus 4 months 2. Baseline versus 10 months 3. 4 months versus 10 months
- measure
- Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups
- timeFrame
- 10 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available