NCT05606523Recrutement en cours
Microbiota and Pancreatic Cancer Cachexia
Résumé
This monocentric study aims at evaluating the effects of fecal microbiota transplantation from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, and healthy volunteers on several cachexia-related parameters of germ-free mice.
Critères d'inclusion
Patients with pancreatic cancer (n=12) • ≥18 years and • Newly diagnosed of pancreatic adenocarcinoma (local or metastatic) and • Tube feeding or parenteral nutrition ≤ 14 days Cachectic pancreatic cancer patients (n=6) • Cachexia according to the Fearon criteria 1: involuntary weight loss \>5% over the last 6 months, or any level of weight loss \>2% and a BMI \<20 kg/m2 or sarcopenia. Sarcopenia will be diagnosed by BIA (fat-free mass index is \<17 kg/m2 in men and \<15 kg/m2 in women) 81, and not by CT, as it is faster and can be performed at the bedside of the patient. Non-cachectic pancreatic cancer patients (n=6) • Normal nutritional state: weight stability (± 2% of habitual weight) over the last 6 months, no anorexia before the diagnosis (appetite rating on a visual analogue scale of 100mm), no known impaired glucose tolerance. Healthy matched subjects (n=12) • ≥18 years and • BMI between 18.5 and 30 kg/m2 and • Absence of chronic or acute disease and • Matching for gender and age (± 5 years) with an included pancreatic cancer patient
Critères d'exclusion
• \< 18 years or • Inability to give consent or • Insufficient knowledge of project language (French, German) or • Pancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversion • Known rheumatologic or immunologic diseases • Therapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- —
- Type d'étude
- Observationnelle
- Pays
- Suisse
- Promoteur
- Genton Graf Laurence(Autre)
- N° de protocole
- 2022-00820
- Pathologies
- Pancreatic Cancer, Microbiota, Cachexia
- Interventions
- —
Lieux · 1
- Geneva, SuisseGeneva University HospitalsRecrute dans ce centre
Au total, dans le monde, le seul centre listé au registre recrute.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 6 décembre 2024).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.