Microbiota and Pancreatic Cancer Cachexia
- Conditions
- Pancreatic CancerMicrobiotaCachexia
- Registration Number
- NCT05606523
- Lead Sponsor
- Genton Graf Laurence
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
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
- < 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body weight changes in mice after fecal material transplantation. Between days 0 and 30 Body weight (g)
- Secondary Outcome Measures
Name Time Method Muscle mass at diagnosis surfaces of the paraspinal and abdominal wall muscles at the level of L3-L4 disk space by CT for pancreatic cancer patients
Nutritional intake at diagnosis by 3-day food diary between cachectic patients non-cachectic patients and healthy volunteers
Differences in fecal microbiota at diagnosis by 16S rRNA gene amplicon sequencing and functional profiles by metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers
Homeostatic model assessment (HOMA)-score at diagnosis by fasting glycemia (mmol/l) and fasting insulinemia (mU/ml)) between cachectic patients non-cachectic patients and healthy volunteers
Glycemia at diagnosis by fasting glycemia (mmol/l) between cachectic patients non-cachectic patients and healthy volunteers
Body weight at diagnosis in kilograms between cachectic patients non-cachectic patients and healthy volunteers
Resting energy expenditure (REE) at diagnosis by indirect calorimetry between cachectic patients non-cachectic patients and healthy volunteers
Waist-to-hip ratio at diagnosis waist circumference (cm) and hip circumference (cm) between cachectic patients non-cachectic patients and healthy volunteers
Fat mass at diagnosis by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers
Fat-free mass at diagnosis by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers
Appetite at diagnosis by fasting level of plasma cholecystokinin between cachectic patients non-cachectic patients and healthy volunteers
Insulinemia at diagnosis by fasting insulinemia (mU/ml) between cachectic patients non-cachectic patients and healthy volunteers
Physical activity at diagnosis by the International Physical Activity Questionnaire (IPAQ) between cachectic patients non-cachectic patients and healthy volunteers
Mortality at diagnosis by tumor progression between cachectic patients non-cachectic patients
Physical function at diagnosis by handgrip strength between cachectic patients non-cachectic patients and healthy volunteers
Quality of life at diagnosis by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC QLQ-C30) between cachectic patients non-cachectic patients and healthy volunteers
Epithelial permeability at diagnosis by fasting levels of plasma glucagon-like peptide-2 between cachectic patients non-cachectic patients and healthy volunteers
Oral microbiota at diagnosis by 16SrRNA gene amplicon sequencing and metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers
GALT function and systemic inflammation at diagnosis by myeloid derived suppressor cells (MDSC) levels and phenotype between cachectic patients non-cachectic patients and healthy volunteers
Trial Locations
- Locations (1)
Geneva University Hospitals
🇨🇭Geneva, Switzerland