Lung Cancer MetastaticNCT06060262
The Alterations of Metabolic Adipo-myokines and Body Composition in End Stage Lung Cancer
An observational study of Lung Cancer Metastatic, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lung Cancer Metastatic
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Feb 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of lung cancer stage III to stage IV
- Adults over 20 years old
- Daily performance status of 0- 2
Who cannot join
- 1. Cardiac stents or pacemakers
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
TSENG CHIA-CHENG, +886 7 731 7123 ext. 8775, cctseng@hotmail.com.tw
About this study
Official title: The Clinical Significance of Metabolic Adipo-myokines and Alterations of Body Composition in Patients With End Stage Lung Cancer
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
Read the 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.
- Conditions
- Lung Cancer Metastatic
- Keywords
- adipo-myokines, body composition, end stage lung cancer, clinical outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of white blood cell change among before, during and after cancer therapy
assessing the change of white blood cell count among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Percentage of body fat change among before, during and after cancer therapy
assessing the change of percentage of body fat among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Percentage of total body water change among before, during and after cancer therapy
assessing the change of total body water percentage among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Percentage of soft lean mass change among before, during and after cancer therapy
assessing the change of soft lean mass percentage among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma CEA change among before, during and after cancer therapy
assessing the change of plasma CEA concentration among week 0, week 4 and week 12
Measured: week 0, week 4 and week 12 after cancer theraphy
Concentration of plasma albumin change among before, during and after cancer therapy
assessing the change of plasma albumin concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma myostatin change among before, during and after cancer therapy
assessing the change of plasma myostatin concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma FSTL-1 change among before, during and after cancer therapy
assessing the change of plasma FSTL-1 concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma IL-6 change among before, during and aftercancer therapy
assessing the change of plasma IL-6 concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma irisin change among before, during and after cancer therapy
assessing the change of plasma irisin concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma adiponectin change among before, during and after cancer therapy
assessing the change of plasma adiponectin concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma MCP-1 change among before, during and after cancer therapy
assessing the change of plasma MCP-1 concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Concentration of plasma aquaporin change among before, during and after cancer therapy
assessing the change of plasma aquaporin concentration among week 0, week 4 and week 12
Measured: week 0 , week 4 and week 12 after cancer theraphy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start2 Feb 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TSENG CHIA-CHENG, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060262
- Sponsor's protocol ID
- 202201448B0
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Metabolic Adipo-myokines and Alterations of Body Composition in Patients With End Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT06060262
- Acronym / sponsor ID
- 202201448B0
- Conditions
- Lung Cancer Metastatic
- Keywords
- adipo-myokines, body composition, end stage lung cancer, clinical outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of lung cancer stage III to stage IV
- Adults over 20 years old
- Daily performance status of 0- 2
Key exclusion criteria (1 listed)
- 1. Cardiac stents or pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of white blood cell change among before, during and after cancer therapy
Time frame: 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
Percentage of body fat change among before, during and after cancer therapy
Time frame: 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
Percentage of total body water change among before, during and after cancer therapy
Time frame: 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
Percentage of soft lean mass change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma CEA change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma albumin change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma myostatin change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma FSTL-1 change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma IL-6 change among before, during and aftercancer therapy
Time frame: 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
Concentration of plasma irisin change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma adiponectin change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma MCP-1 change among before, during and after cancer therapy
Time frame: 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
Concentration of plasma aquaporin change among before, during and after cancer therapy
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TSENG CHIA-CHENG principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Metastatic, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TSENG CHIA-CHENG (+886 7 731 7123 ext. 8775, cctseng@hotmail.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of white blood cell change among before, during and after cancer therapy (time frame: week 0 , week 4 and week 12 after cancer theraphy). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.