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JOURNAL ONKOLOGIE – STUDIE
EXTRA

Microbiota and Pancreatic Cancer Cachexia

Rekrutierend

NCT-Nummer:
NCT05606523

Studienbeginn:
August 2022

Letztes Update:
28.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Pancreatic Neoplasms, Wasting Syndrome, Cachexia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Genton Graf Laurence

Collaborator:
-

Studienleiter

Laurence Genton Graf, Prof
Principal Investigator
Geneva University Hospitals (HUG)

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Body weight changes in mice after fecal material transplantation. (Time Frame - Between days 0 and 30):
Body weight (g)



Secondary outcome:

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

Studien-Arme

  • Cachectic patients with pancreatic cancer
    Measurements and sample collection at one timepoint.
  • Non-cachectic patients with pancreatic cancer
    Measurements and sample collection at one timepoint.
  • Healthy volunteers
    Measurements and sample collection at one timepoint.

Quelle: ClinicalTrials.gov


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