Microbiota and Pancreatic Cancer Cachexia

Plain-language summary

This is an observational study that examines the relationship between gut microbiota and cachexia (severe involuntary weight and muscle loss) in people with pancreatic cancer. Adults aged 18 and older newly diagnosed with pancreatic adenocarcinoma (both with and without cachexia), along with healthy matched individuals for comparison, are included. It is a non-interventional (observational) study and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Genton Graf Laurence

Start date

8/1/2022

Estimated completion

4/30/2025

Countries

Switzerland

Related genes

Locations

• Geneva, Switzerland

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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