CachexiaLUCAPETNCT05912465
Predicting Lung Cancer-Associated Cachexia With PET Imaging
A study testing Stress Reduction Training in people with Cachexia and Lung Neoplasm, run by Medical University of Vienna at 3 sites in 3 countries.
Trial summary
This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Lung Neoplasm
- What is being tested?
- Stress Reduction Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jul 2023to 1 Mar 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Confirmed diagnosis of lung cancer.
- Willingness to participate in the study and provide informed consent.
- Ability to comply with study procedures and follow-up visits.
Who cannot join
- Previous history of any other malignancy within the last 5 years, excluding non-melanoma skin cancer.
- Concurrent participation in another clinical trial involving an investigational product.
- Known contraindications or intolerance to PET/CT imaging or fluorodeoxyglucose (FDG).
- Presence of severe comorbidities that may interfere with study participation or affect the interpretation of results.
- Pregnant or lactating women, or those planning to become pregnant during the study period.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Marcus Hacker, Prof., MD, +43 140400 55310, marcus.hacker@meduniwien.ac.at
Josef Yu, MD
Germany1 site, 1 recruiting
- Not yet recruiting
University of Leipzig Medical Center
Leipzig
Osama Sabri, Prof.
Italy1 site, 1 recruiting
- Not yet recruiting
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence
Roberto Sciagra, Prof.
About this study
Official title: The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients
This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.
Read the detailed description
Title: Investigation of the Relationship Between Cancer Cachexia, Stress, and Metabolic Changes in Lung Cancer Patients
Background: Cancer cachexia is a debilitating syndrome characterized by progressive weight loss, muscle wasting, and metabolic abnormalities. It significantly impacts patients' quality of life and survival outcomes. Psychological stress has been suggested as a potential contributor to cachexia development and progression. This study aims to investigate the association between cancer cachexia, stress levels, and metabolic changes in lung cancer patients.
Methods: This multicenter, prospective observational study will enroll 150 lung cancer patients. Eligible participants will undergo comprehensive assessments, including medical history review, physical examinations, laboratory tests, and diagnostic imaging. Cancer cachexia will be diagnosed based on established criteria, including weight loss, reduced food intake, and systemic inflammation markers. Psychological stress will be evaluated using validated questionnaires and stress biomarkers. Metabolic changes will be assessed through positron emission tomography-computed tomography (PET-CT) scans to measure fluorodeoxyglucose (FDG) uptake in organs and lesions.
Primary Objectives: The primary objective is to determine differences in FDG uptake between cachectic and non-cachectic lung cancer patients in various organs and lesions. Secondary objectives include evaluating changes in amygdalar FDG uptake after stress intervention and exploring the relationship between stress, inflammatory markers, and metabolic changes.
Statistical Analysis: Student's t-test will be used to compare FDG uptake between groups, and descriptive statistics will be calculated for each brain region. Sample size calculations indicate a need for approximately 30 subjects per group to detect significant differences. Data will be analyzed using appropriate statistical software.
Ethical Considerations: Informed consent will be obtained from all participants, and the study will adhere to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocol has been submitted to the Ethics Committee and regulatory authorities for approval.
Conclusion: This study aims to provide insights into the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients. By investigating FDG uptake in different organs and lesions, as well as amygdalar FDG uptake before and after stress intervention, this research may contribute to the development of targeted interventions for cachexia management and improve patient outcomes.
- Conditions
- Cachexia, Lung Neoplasm
- Being tested
- Stress Reduction Training
- Keywords
- Cancer cachexia, Positron emission tomography, Metabolic changes, Lung cancer, Muscle wasting, Computed tomography, Fluorodeoxyglucose F18, Organ connection
- Medical subject headings
- Cachexia, Lung Neoplasms, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Reduction TrainingOther
A subgroup of patients from Vienna will undergo an additional PET/CT scan after the first follow-up PET/CT, which takes place one month after stress reduction training. The stress reduction training involves performing a breathing technique.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Naive Lung Cancer Patients | Experimental | This arm includes 150 treatment-naive lung cancer patients. Assessments include medical history, physical exams, lab tests, and imaging. Objective: investigate cancer cachexia, stress, and metabolic changes. Cachexia criteria: weight loss, reduced food intake, inflammation markers. Stress assessment: questionnaires, biomarkers. Metabolic changes measured by PET-CT scans analyzing FDG uptake in organs/lesions. Data will uncover the relationship between cancer cachexia, stress, and metabolic changes in treatment-naive lung cancer patients, leading to improved interventions/outcomes. Receives: Other: Stress Reduction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in FDG uptake (measured as SUVmean, max, min, peak) in organs, muscle, fat tissue between Cachectic and Non-Cachectic Lung Cancer Patients
Measurement of fluorodeoxyglucose (FDG) uptake in various organs and lesions to characterize the metabolic differences between cachectic and non-cachectic lung cancer patients.
Measured: F/U for 12 month minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The overall model of this study involves enrolling a total of 150 patients from three different sites. These patients will undergo baseline PET/CT imaging to assess their metabolic changes, as well as provide clinical information through medical history review and physical examinations. Additionally, blood samples will be collected for laboratory tests, and patients will complete questionnaires to evaluate psychological stress levels. This comprehensive approach aims to gather a range of data including imaging, clinical information, blood biomarkers, and psychological assessments to investigate the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Careggi Hospital, University of Copenhagen
- Responsible party
- Principal investigator, Univ.-Prof. Dr. Marcus Hacker, Medical University of Vienna
- Investigators
- Marcus Hacker, Prof., Principal investigator, Medical University of Vienna, Department of Radiology and Nuclear MedicineThomas Beyer, Prof., Principal investigator, Medical University of Vienna, Center for Medical Physics and Biomedical EngineeringOsama Sabri, Prof., Principal investigator, University of Leipzig Medical CenterRoberto Sciagrà, Prof., Principal investigator, Careggi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912465
- Sponsor's protocol ID
- 2091/2022
- Acronym
- LUCAPET
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shiyam Sundar LK, Yu J, Muzik O, Kulterer OC, Fueger B, Kifjak D, Nakuz T, Shin HM, Sima AK, Kitzmantl D, Badawi RD, Nardo L, Cherry SR, Spencer BA, Hacker M, Beyer T. Fully Automated, Semantic Segmentation of Whole-Body 18F-FDG PET/CT Images Based on Data-Centric Artificial Intelligence. J Nucl Med. 2022 Dec;63(12):1941-1948. doi: 10.2967/jnumed.122.264063. Epub 2022 Jun 30.
PubMed 35772962Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
PubMed 21296615
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05912465
- Acronym / sponsor ID
- LUCAPET / 2091/2022
- Conditions
- Cachexia, Lung Neoplasm
- Keywords
- Cancer cachexia, Positron emission tomography, Metabolic changes, Lung cancer, Muscle wasting, Computed tomography, Fluorodeoxyglucose F18, Organ connection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Leipzig, Careggi Hospital, University of Copenhagen
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 22 Jun 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.
This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.
Detailed description
Title: Investigation of the Relationship Between Cancer Cachexia, Stress, and Metabolic Changes in Lung Cancer Patients
Background: Cancer cachexia is a debilitating syndrome characterized by progressive weight loss, muscle wasting, and metabolic abnormalities. It significantly impacts patients' quality of life and survival outcomes. Psychological stress has been suggested as a potential contributor to cachexia development and progression. This study aims to investigate the association between cancer cachexia, stress levels, and metabolic changes in lung cancer patients.
Methods: This multicenter, prospective observational study will enroll 150 lung cancer patients. Eligible participants will undergo comprehensive assessments, including medical history review, physical examinations, laboratory tests, and diagnostic imaging. Cancer cachexia will be diagnosed based on established criteria, including weight loss, reduced food intake, and systemic inflammation markers. Psychological stress will be evaluated using validated questionnaires and stress biomarkers. Metabolic changes will be assessed through positron emission tomography-computed tomography (PET-CT) scans to measure fluorodeoxyglucose (FDG) uptake in organs and lesions.
Primary Objectives: The primary objective is to determine differences in FDG uptake between cachectic and non-cachectic lung cancer patients in various organs and lesions. Secondary objectives include evaluating changes in amygdalar FDG uptake after stress intervention and exploring the relationship between stress, inflammatory markers, and metabolic changes.
Statistical Analysis: Student's t-test will be used to compare FDG uptake between groups, and descriptive statistics will be calculated for each brain region. Sample size calculations indicate a need for approximately 30 subjects per group to detect significant differences. Data will be analyzed using appropriate statistical software.
Ethical Considerations: Informed consent will be obtained from all participants, and the study will adhere to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocol has been submitted to the Ethics Committee and regulatory authorities for approval.
Conclusion: This study aims to provide insights into the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients. By investigating FDG uptake in different organs and lesions, as well as amygdalar FDG uptake before and after stress intervention, this research may contribute to the development of targeted interventions for cachexia management and improve patient outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The overall model of this study involves enrolling a total of 150 patients from three different sites. These patients will undergo baseline PET/CT imaging to assess their metabolic changes, as well as provide clinical information through medical history review and physical examinations. Additionally, blood samples will be collected for laboratory tests, and patients will complete questionnaires to evaluate psychological stress levels. This comprehensive approach aims to gather a range of data including imaging, clinical information, blood biomarkers, and psychological assessments to investigate the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients.
| Arm | Type | Receives |
|---|---|---|
| Treatment-Naive Lung Cancer Patients | Experimental | Other: Stress Reduction TrainingThis arm includes 150 treatment-naive lung cancer patients. Assessments include medical history, physical exams, lab tests, and imaging. Objective: investigate cancer cachexia, stress, and metabolic changes. Cachexia criteria: weight loss, reduced food intake, inflammation markers. Stress assessment: questionnaires, biomarkers. Metabolic changes measured by PET-CT scans analyzing FDG uptake in organs/lesions. Data will uncover the relationship between cancer cachexia, stress, and metabolic changes in treatment-naive lung cancer patients, leading to improved interventions/outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older.
- Confirmed diagnosis of lung cancer.
- Willingness to participate in the study and provide informed consent.
- Ability to comply with study procedures and follow-up visits.
Key exclusion criteria (6 listed)
- Previous history of any other malignancy within the last 5 years, excluding non-melanoma skin cancer.
- Concurrent participation in another clinical trial involving an investigational product.
- Known contraindications or intolerance to PET/CT imaging or fluorodeoxyglucose (FDG).
- Presence of severe comorbidities that may interfere with study participation or affect the interpretation of results.
- Pregnant or lactating women, or those planning to become pregnant during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Reduction TrainingA subgroup of patients from Vienna will undergo an additional PET/CT scan after the first follow-up PET/CT, which takes place one month after stress reduction training. The stress reduction training involves performing a breathing technique. | Other | Treatment-Naive Lung Cancer Patients |
Primary outcome
Differences in FDG uptake (measured as SUVmean, max, min, peak) in organs, muscle, fat tissue between Cachectic and Non-Cachectic Lung Cancer Patients
Time frame: F/U for 12 month minimum
Measurement of fluorodeoxyglucose (FDG) uptake in various organs and lesions to characterize the metabolic differences between cachectic and non-cachectic lung cancer patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 35772962Shiyam Sundar LK, Yu J, Muzik O, Kulterer OC, Fueger B, Kifjak D, Nakuz T, Shin HM, Sima AK, Kitzmantl D, Badawi RD, Nardo L, Cherry SR, Spencer BA, Hacker M, Beyer T. Fully Automated, Semantic Segmentation of Whole-Body 18F-FDG PET/CT Images Based on Data-Centric Artificial Intelligence. J Nucl Med. 2022 Dec;63(12):1941-1948. doi: 10.2967/jnumed.122.264063. Epub 2022 Jun 30.
- Background: PubMed 21296615Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cachexia
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruitingPhase 2/3
OLE Study Subsequent to Parent Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Enrolling by invitation
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Moderate Acute Malnutrition (MAM), Undernutrition
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
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.
Marcus Hacker, Prof. principal investigator
Medical University of Vienna, Department of Radiology and Nuclear Medicine
Thomas Beyer, Prof. principal investigator
Medical University of Vienna, Center for Medical Physics and Biomedical Engineering
Osama Sabri, Prof. principal investigator
University of Leipzig Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Reduction Training in people with Cachexia and Lung Neoplasm, run by Medical University of Vienna at 3 sites in 3 countries.
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 4 inclusion and 6 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Italy. 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 Marcus Hacker, Prof., MD (+43 140400 ext. 55310, marcus.hacker@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in FDG uptake (measured as SUVmean, max, min, peak) in organs, muscle, fat tissue between Cachectic and Non-Cachectic Lung Cancer Patients (time frame: F/U for 12 month minimum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912465, which also lists 2 linked publications.
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 27 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.