Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Switzerland
Geneva University Hospitals
RECRUITING
Geneva
Contact Information
Primary
Laurence Genton Graf, Prof
laurence.genton@hcuge.ch
+41 22 3729344
Backup
Alexandra Hemmer, MSc
alexandra.hemmer@hcuge.ch
+41795530491
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 24
Treatments
Cachectic patients with pancreatic cancer
Measurements and sample collection at one timepoint.
Non-cachectic patients with pancreatic cancer
Measurements and sample collection at one timepoint.
Healthy volunteers
Measurements and sample collection at one timepoint.
Related Therapeutic Areas
Sponsors
Leads: Genton Graf Laurence

This content was sourced from clinicaltrials.gov