NCT05606523Recruiting
Microbiota and Pancreatic Cancer Cachexia
Summary
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.
Inclusion criteria
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
Exclusion criteria
• \< 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
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland
- Sponsor
- Genton Graf Laurence(Other)
- Protocol no.
- 2022-00820
- Conditions
- Pancreatic Cancer, Microbiota, Cachexia
- Interventions
- —
Locations · 1
- Geneva, SwitzerlandGeneva University HospitalsRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: December 6, 2024).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.