Microbiota and Pancreatic Cancer Cachexia
Recruiting · NCT05606523 · Observational (researchers observe without assigning treatment) · Lead sponsor: Genton Graf Laurence
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Geneva University Hospitals - Geneva, Switzerland