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Microbiota and Pancreatic Cancer Cachexia
RECRUITINGSponsored by Genton Graf Laurence
Actively Recruiting
SponsorGenton Graf Laurence
Started2022-08-01
Est. completion2025-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05606523
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions5
CachexiaCancerMicrobiotaPancreatic CancerWeight Loss
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Actively Recruiting
SponsorGenton Graf Laurence
Started2022-08-01
Est. completion2025-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05606523