Microbiota and Pancreatic Cancer Cachexia

Trial Title: Microbiota and Pancreatic Cancer Cachexia

NCT ID: NCT05606523

Condition: Pancreatic Cancer
Microbiota
Cachexia

Conditions: Official terms:
Pancreatic Neoplasms
Wasting Syndrome
Cachexia

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Detailed description: Aim: Evaluating the effects of fecal microbiota transplantation (FMT) from 6 newly diagnosed cachectic and 6 non-cachectic pancreatic cancer patients, and 12 healthy age-and sex-matched volunteers on several cachexia-related parameters of 96 germ-free mice (4 per donor) over a 30-day period. The fecal material of all 12 pancreatic cancer patients will be collected at diagnosis before any cancer treatment onset. Hypothesis: FMT of cachectic patients with pancreas cancer, naïve of any anti-cancer treatment and artificial nutrition, into germ-free mice impairs weight gain, in contrast to FMT of non-cachectic patients and healthy controls.

Criteria for eligibility:

Study pop:
We will consider the fecal samples of 12 patients at diagnosis of pancreatic cancer including 6 patients with cachexia and 6 patients without cachexia, and therefore naïve of any anti-cancer treatment and artificial nutritional support. We will also include 12 healthy volunteers matched for gender and age (± 5 years) with the pancreatic cancer patients.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Geneva University Hospitals

Address:
City: Geneva
Zip: 1211
Country: Switzerland

Status: Recruiting

Contact:
Last name: Laurence Genton Graf, Prof

Investigator:
Last name: Laurence Genton Graf, Prof
Email: Principal Investigator

Start date: August 1, 2022

Completion date: April 30, 2025

Lead sponsor:
Agency: Genton Graf Laurence
Agency class: Other

Source: University Hospital, Geneva

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05606523