Trial Title:
Predicting Lung Cancer-Associated Cachexia With PET Imaging
NCT ID:
NCT05912465
Condition:
Cachexia
Lung Neoplasm
Conditions: Official terms:
Lung Neoplasms
Wasting Syndrome
Cachexia
Conditions: Keywords:
Cancer cachexia
Positron emission tomography
Metabolic changes
Lung cancer
Muscle wasting
Computed tomography
Fluorodeoxyglucose F18
Organ connection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Stress Reduction Training
Description:
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.
Arm group label:
Treatment-Naive Lung Cancer Patients
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical University of Vienna
Address:
City:
Vienna
Zip:
1090
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Marcus Hacker, Prof., MD
Phone:
+43 140400 55310
Email:
marcus.hacker@meduniwien.ac.at
Investigator:
Last name:
Josef Yu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Andreas Bergthaler, Prof.
Email:
Sub-Investigator
Facility:
Name:
University of Leipzig Medical Center
Address:
City:
Leipzig
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Osama Sabri, Prof.
Facility:
Name:
AOUC Azienda Ospedaliero-Universitaria Careggi
Address:
City:
Florence
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Roberto Sciagra, Prof.
Start date:
July 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Medical University of Vienna
Agency class:
Other
Collaborator:
Agency:
University of Leipzig
Agency class:
Other
Collaborator:
Agency:
Careggi Hospital
Agency class:
Other
Collaborator:
Agency:
University of Copenhagen
Agency class:
Other
Source:
Medical University of Vienna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05912465
https://www.meduniwien.ac.at/web/en/forschung/projekte/lucapet/lucapet/
