Microbiota and Pancreatic Cancer Cachexia

Last updated: December 3, 2024
Sponsor: Genton Graf Laurence
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT05606523
2022-00820
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 thelast 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 <15kg/m2 in women) 81, and not by CT, as it is faster and can be performed at thebedside of the patient. Non-cachectic pancreatic cancer patients (n=6)

  • Normal nutritional state: weight stability (± 2% of habitual weight) over the last 6months, no anorexia before the diagnosis (appetite rating on a visual analogue scaleof 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

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 majorsurgery 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

Study Design

Total Participants: 24
Study Start date:
August 01, 2022
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Geneva University Hospitals

    Geneva, 1211
    Switzerland

    Active - Recruiting

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