Effects of gut bacteria on weight loss in pancreatic cancer patients

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

This study is testing how gut bacteria from pancreatic cancer patients and healthy people affect weight loss in mice to see if it can help understand cachexia in cancer patients.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Geneva (Academic / other)
• Locations: 1 site (Geneva)
• Trial ID: NCT05606523 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the impact of fecal microbiota transplantation (FMT) from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, as well as healthy volunteers, on cachexia-related parameters in germ-free mice. The study involves collecting fecal samples from 12 pancreatic cancer patients at diagnosis, before any treatment, and from 12 healthy age- and sex-matched volunteers. The effects of these samples will be assessed over a 30-day period in 96 germ-free mice to determine how the microbiota influences weight gain and cachexia. The hypothesis is that FMT from cachectic patients will impair weight gain compared to FMT from non-cachectic patients and healthy controls.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed pancreatic adenocarcinoma, either cachectic or non-cachectic.

Not a fit: Patients who are not newly diagnosed with pancreatic cancer or those who have received prior cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new insights into the role of gut microbiota in managing cachexia in pancreatic cancer patients.

How similar studies have performed: While the approach of using fecal microbiota transplantation is gaining interest, this specific application in pancreatic cancer cachexia is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Geneva

• Geneva University Hospitals — Geneva, Switzerland (Recruiting)

Study contacts

• Principal investigator: Laurence Genton Graf, Prof — Geneva University Hospitals (HUG)
• Study coordinator: Laurence Genton Graf, Prof

Conditions Pancreatic Cancer; Microbiota; Cachexia