Microbiota and Pancreatic Cancer Cachexia

Official title

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

Overview

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.

Primary outcome measures

• Body weight changes in mice after fecal material transplantation. [Time frame: Between days 0 and 30]

Secondary outcome measures (12)

• Differences in fecal microbiota [Time frame: at diagnosis]
• Body weight [Time frame: at diagnosis]
• Waist-to-hip ratio [Time frame: at diagnosis]
• Fat mass [Time frame: at diagnosis]
• Fat-free mass [Time frame: at diagnosis]
• Muscle mass [Time frame: at diagnosis]
• Nutritional intake [Time frame: at diagnosis]
• Resting energy expenditure (REE) [Time frame: at diagnosis]
• Appetite [Time frame: at diagnosis]
• Appetite [Time frame: at diagnosis]
• Appetite [Time frame: at diagnosis]
• Appetite [Time frame: at diagnosis]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Switzerland · 1 center

• Geneva University Hospitals — Geneva

Identifiers

NCT: NCT05606523 · 2022-00820

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗