NCT05606523Recruiting
Microbiota and Pancreatic Cancer Cachexia
Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 25 Aug 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Genton Graf Laurence
- Diseases
- Pancreatic cancer
- NCT number
- NCT05606523
What you commit to
- Study type: Observational
- Planned participants: 24
- From 1 Aug 2022 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversion
- Therapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion
Other illness
- Known rheumatologic or immunologic diseases
Age
- \< 18 years or
Other
- Inability to give consent or
- Insufficient knowledge of project language (French, German) or
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Geneva University Hospitals Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.