Clinical trial NCT06060262: The Alterations of Metabolic Adipo-myokines and Body Composition in End Stage Lung Cancer
Official title: The Clinical Significance of Metabolic Adipo-myokines and Alterations of Body Composition in Patients With End Stage Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Metastatic
Keywords: adipo-myokines
body composition
end stage lung cancer
clinical outcomes
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who diagnosed with lung cancer including small cell and non-small cell lung cancer from 2023-03-1to 2026-02-28 will be eligible for the study. Every patients' performance status must be in 0-2 and can receive any cancer treatments including chemotherapy.

Brief summary: The investigators conduct this prospective study and wish to elucidate the association of serial change of body composition, serum adipo-myokines and adverse effect of chemotherapy and lung cancer prognosis

Detailed description: Recently, the skeletal muscle was viewed as having biochemical function in additional to traditional biomechanical function. What's more important is that muscles could synthesize and release adipo-myokines during contraction. The adipo-myokines can affect muscle regeneration, muscle atrophy, muscle mass, autophagy, fatty acid oxidation and mitochondrial biosynthesis.Studies have also found that exercise can promote the function of macrophages and regulate both pro-inflammatory and anti-inflammatory phenotypes, helping the body to establish a stable immune balance.

Since body composition can illustrate malnutrition status and cancer cachexia present, and body composition can be affected by serum adipo-myokines level. Therefore, the investigators conduct this study and wish to see the association of serial body composition and serum adipo-myokines changes with lung cancer clinical outcomes and adverse effect of any anti-cancer regimen.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of lung cancer stage III to stage IV
2. Adults over 20 years old
3. Daily performance status of 0- 2

Exclusion Criteria:

1. Cardiac stents or pacemakers

Primary outcomes:
measure: Number of white blood cell change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Percentage of body fat change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Percentage of total body water change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Percentage of soft lean mass change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma CEA change among before, during and after cancer therapy
timeFrame: week 0, week 4 and week 12 after cancer theraphy
measure: Concentration of plasma albumin change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma myostatin change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma FSTL-1 change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma IL-6 change among before, during and aftercancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma irisin change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma adiponectin change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma MCP-1 change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
measure: Concentration of plasma aquaporin change among before, during and after cancer therapy
timeFrame: week 0 , week 4 and week 12 after cancer theraphy
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: TSENG CHIA-CHENG
role: PRINCIPAL_INVESTIGATOR
References: