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Microbiota and Pancreatic Cancer Cachexia

ConditionsPancreatic CancerMicrobiotaCachexia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGenton Graf Laurence

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥18 years and

Newly diagnosed of pancreatic adenocarcinoma (local or metastatic) and

Tube feeding or parenteral nutrition ≤ 14 days

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)

Disqualifiers

< 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

Trial population

We will consider the fecal samples of 12 patients at diagnosis of pancreatic cancer including 6 patients with cachexia and 6 patients without cachexia, and therefore naïve of any anti-cancer treatment and artificial nutritional support. We will also include 12 healthy volunteers matched for gender and age (± 5 years) with the pancreatic cancer patients.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

24 Participants
are grouped into 3 trial groups
Group A: Cachectic patients with pancreatic cancer
Group B: Non-cachectic patients with pancreatic cancer
Group C: Healthy volunteers

Trial outcomes

Primary outcomes

1

Body weight changes in mice after fecal material transplantation.

Body weight (g)

Time frame
Between days 0 and 30

Secondary outcomes

1

Differences in fecal microbiota

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

Time frame
at diagnosis
2

Body weight

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

Time frame
at diagnosis
3

Waist-to-hip ratio

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

Time frame
at diagnosis
4

Fat mass

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

Time frame
at diagnosis

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genton Graf Laurence

Lead sponsor

University Hospital, Geneva

Sponsor institution

Source ClinicalTrials.gov
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