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The Alterations of Metabolic Adipo-myokines and Body Composition in End Stage Lung Cancer

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06060262
Collaborator
(none)
600
Enrollment
1
Location
33.9
Anticipated Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Clinical Significance of Metabolic Adipo-myokines and Alterations of Body Composition in Patients With End Stage Lung Cancer
    Actual Study Start Date :
    Feb 2, 2023
    Anticipated Primary Completion Date :
    Nov 30, 2025
    Anticipated Study Completion Date :
    Nov 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Number of white blood cell change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of white blood cell count among week 0, week 4 and week 12

    2. Percentage of body fat change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of percentage of body fat among week 0, week 4 and week 12

    3. Percentage of total body water change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of total body water percentage among week 0, week 4 and week 12

    4. Percentage of soft lean mass change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of soft lean mass percentage among week 0, week 4 and week 12

    5. Concentration of plasma CEA change among before, during and after cancer therapy [week 0, week 4 and week 12 after cancer theraphy]

      assessing the change of plasma CEA concentration among week 0, week 4 and week 12

    6. Concentration of plasma albumin change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma albumin concentration among week 0, week 4 and week 12

    7. Concentration of plasma myostatin change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma myostatin concentration among week 0, week 4 and week 12

    8. Concentration of plasma FSTL-1 change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma FSTL-1 concentration among week 0, week 4 and week 12

    9. Concentration of plasma IL-6 change among before, during and aftercancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma IL-6 concentration among week 0, week 4 and week 12

    10. Concentration of plasma irisin change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma irisin concentration among week 0, week 4 and week 12

    11. Concentration of plasma adiponectin change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma adiponectin concentration among week 0, week 4 and week 12

    12. Concentration of plasma MCP-1 change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma MCP-1 concentration among week 0, week 4 and week 12

    13. Concentration of plasma aquaporin change among before, during and after cancer therapy [week 0 , week 4 and week 12 after cancer theraphy]

      assessing the change of plasma aquaporin concentration among week 0, week 4 and week 12

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Chang Gung Memorial Hospital Kaohsiung City Taiwan 83301

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    • Principal Investigator: TSENG CHIA-CHENG, Chang Gung Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT06060262
    Other Study ID Numbers:
    • 202201448B0
    First Posted:
    Sep 29, 2023
    Last Update Posted:
    Sep 29, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chang Gung Memorial Hospital
    adipo-myokines
    body composition
    end stage lung cancer
    clinical outcomes
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Sep 29, 2023