RecruitingNCT05606523
Microbiota and Pancreatic Cancer Cachexia
Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study
Sponsor
Genton Graf Laurence
Enrollment
24 participants
Start Date
Aug 1, 2022
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria12
- 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 Criteria6
- \< 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05606523
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