Microbiota and Pancreatic Cancer Cachexia

Launched by GENTON GRAF LAURENCE · Oct 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the bacteria in our gut, known as microbiota, may affect a condition called cachexia in patients with pancreatic cancer. Cachexia is a serious condition that causes significant weight loss and weakness due to the cancer itself. The researchers want to see if transferring gut bacteria from pancreatic cancer patients who are experiencing cachexia, patients who are not, and healthy volunteers into specially treated mice can help understand how these bacteria impact weight loss and overall health in cancer patients.

To participate in this study, you need to be at least 18 years old and have been newly diagnosed with pancreatic cancer. There are specific criteria for being either cachectic (having involuntary weight loss) or non-cachectic (stable weight) to be eligible. Healthy volunteers are also welcome if they meet age and weight guidelines. If you join this trial, you will help researchers learn more about the relationship between gut bacteria and cancer-related weight loss, which could lead to better treatments in the future. The study is currently recruiting participants, and it’s important to note that certain health conditions or recent treatments could affect eligibility.

Gender

ALL

Eligibility criteria

• 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