Predicting Lung Cancer-Associated Cachexia With PET Imaging

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05912465

Studienbeginn:
Juli 2023

Letztes Update:
27.06.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Wasting Syndrome, Cachexia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Vienna

Collaborator:
University of Leipzig, Careggi Hospital, University of Copenhagen,

Studienleiter

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

Roberto Sciagrà, Prof.
Principal Investigator
Careggi University Hospital

Kontakt

Marcus Hacker, Prof., MD
Kontakt:
Phone: +43 140400
Phone (ext.): 55310
E-Mail: marcus.hacker@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

University of Leipzig Medical Center
Leipzig
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Osama Sabri, Prof.» Ansprechpartner anzeigen

Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Marcus Hacker, Prof., MD
Phone: +43 140400 55310
E-Mail: marcus.hacker@meduniwien.ac.at» Ansprechpartner anzeigen

AOUC Azienda Ospedaliero-Universitaria Careggi
Florence
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Roberto Sciagra, Prof.» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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.

Geprüfte Regime

Stress Reduction Training:
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.

Quelle: ClinicalTrials.gov

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