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NCT Number: NCT05606523

Microbiota and Pancreatic Cancer Cachexia

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.

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Key information

Conditions

Pancreatic Cancer Body Weight Body Weight Changes Cachexia Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Microbiota Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, 1211, Switzerland

Location status: Recruiting

Location contact

Laurence Genton Graf, Prof

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Body weight changes in mice after fecal material transplantation.

    Time frame: Between days 0 and 30

    Body weight (g)

Secondary outcomes

  1. Differences in fecal microbiota

    Time frame: at diagnosis

    by 16S rRNA gene amplicon sequencing and functional profiles by metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers

  2. Body weight

    Time frame: at diagnosis

    in kilograms between cachectic patients non-cachectic patients and healthy volunteers

  3. Waist-to-hip ratio

    Time frame: at diagnosis

    waist circumference (cm) and hip circumference (cm) between cachectic patients non-cachectic patients and healthy volunteers

  4. Fat mass

    Time frame: at diagnosis

    by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers

  5. Fat-free mass

    Time frame: at diagnosis

    by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers

  6. Muscle mass

    Time frame: at diagnosis

    surfaces of the paraspinal and abdominal wall muscles at the level of L3-L4 disk space by CT for pancreatic cancer patients

  7. Nutritional intake

    Time frame: at diagnosis

    by 3-day food diary between cachectic patients non-cachectic patients and healthy volunteers

  8. Resting energy expenditure (REE)

    Time frame: at diagnosis

    by indirect calorimetry between cachectic patients non-cachectic patients and healthy volunteers

  9. Appetite

    Time frame: at diagnosis

    by visual analogue scale ranging from 0 to 100 mm between cachectic patients non-cachectic patients and healthy volunteers

  10. Appetite

    Time frame: at diagnosis

    by fasting level of plasma ghrelin between cachectic patients non-cachectic patients and healthy volunteers

  11. Appetite

    Time frame: at diagnosis

    by fasting level of plasma leptin between cachectic patients non-cachectic patients and healthy volunteers

  12. Appetite

    Time frame: at diagnosis

    by fasting level of plasma glucagon-like peptide-1 (GLP-1) between cachectic patients non-cachectic patients and healthy volunteers

  13. Appetite

    Time frame: at diagnosis

    by fasting level of plasma neuropeptide Y between cachectic patients non-cachectic patients and healthy volunteers

  14. Appetite

    Time frame: at diagnosis

    by fasting level of plasma cholecystokinin between cachectic patients non-cachectic patients and healthy volunteers

  15. Homeostatic model assessment (HOMA)-score

    Time frame: at diagnosis

    by fasting glycemia (mmol/l) and fasting insulinemia (mU/ml)) between cachectic patients non-cachectic patients and healthy volunteers

  16. Glycemia

    Time frame: at diagnosis

    by fasting glycemia (mmol/l) between cachectic patients non-cachectic patients and healthy volunteers

  17. Insulinemia

    Time frame: at diagnosis

    by fasting insulinemia (mU/ml) between cachectic patients non-cachectic patients and healthy volunteers

  18. Physical function

    Time frame: at diagnosis

    by handgrip strength between cachectic patients non-cachectic patients and healthy volunteers

  19. Physical activity

    Time frame: at diagnosis

    by the International Physical Activity Questionnaire (IPAQ) between cachectic patients non-cachectic patients and healthy volunteers

  20. Quality of life

    Time frame: 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

  21. Mortality

    Time frame: at diagnosis

    by tumor progression between cachectic patients non-cachectic patients

  22. Oral microbiota

    Time frame: at diagnosis

    by 16SrRNA gene amplicon sequencing and metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers

  23. Epithelial permeability

    Time frame: at diagnosis

    by fasting levels of plasma zonulin between cachectic patients non-cachectic patients and healthy volunteers

  24. Epithelial permeability

    Time frame: at diagnosis

    by fasting levels of plasma lipopolysaccharide-binding protein between cachectic patients non-cachectic patients and healthy volunteers

  25. Epithelial permeability

    Time frame: at diagnosis

    by fasting levels of plasma glucagon-like peptide-2 between cachectic patients non-cachectic patients and healthy volunteers

  26. GALT function and systemic inflammation

    Time frame: at diagnosis

    by fasting plasma level of C-reactive protein (CRP) and cytokines between cachectic patients non-cachectic patients and healthy volunteers

  27. GALT function and systemic inflammation

    Time frame: at diagnosis

    by peripheral blood T regulatory cells (Tregs) levels and phenotype between cachectic patients non-cachectic patients and healthy volunteers

  28. GALT function and systemic inflammation

    Time frame: at diagnosis

    by myeloid derived suppressor cells (MDSC) levels and phenotype between cachectic patients non-cachectic patients and healthy volunteers

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Hemmer, MSc

CONTACT

[email protected]

+41795530491

Laurence Genton Graf, Prof

CONTACT

[email protected]

+41 22 3729344

Sponsors and collaborators

Lead sponsor

Genton Graf Laurence

Other

Registry information

Official study title

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

Acronym: EXTRA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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