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NCT05606523
Microbiota and Pancreatic Cancer Cachexia
Conditions: Pancreatic Cancer, Microbiota, Cachexia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 24
Sponsor: Genton Graf Laurence
Location: Switzerland
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.
Eligibility Criteria
Inclusion Criteria:Patients with pancreatic cancer (n=12)≥18 years andNewly diagnosed of pancreatic adenocarcinoma (local or metastatic) andTube feeding or parenteral nutrition ≤ 14 daysCachectic 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 andBMI between 18.5 and 30 kg/m2 andAbsence of chronic or acute disease andMatching for gender and age (± 5 years) with an included pancreatic cancer patientExclusion Criteria:< 18 years orInability to give consent orInsufficient knowledge of project language (French, German) orPancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversionKnown rheumatologic or immunologic diseasesTherapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion
Source: ClinicalTrials.gov (NCT05606523). StuddyBuddy aggregates publicly available trial information.