Microbiota and Pancreatic Cancer Cachexia

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Body weight changes in mice after fecal material transplantation. [Срок оценки: Between days 0 and 30]

Вторичные конечные точки (12)

• Differences in fecal microbiota [Срок оценки: at diagnosis]
• Body weight [Срок оценки: at diagnosis]
• Waist-to-hip ratio [Срок оценки: at diagnosis]
• Fat mass [Срок оценки: at diagnosis]
• Fat-free mass [Срок оценки: at diagnosis]
• Muscle mass [Срок оценки: at diagnosis]
• Nutritional intake [Срок оценки: at diagnosis]
• Resting energy expenditure (REE) [Срок оценки: at diagnosis]
• Appetite [Срок оценки: at diagnosis]
• Appetite [Срок оценки: at diagnosis]
• Appetite [Срок оценки: at diagnosis]
• Appetite [Срок оценки: at diagnosis]

Критерии участия

Критерии включения

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

Критерии исключения

• < 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Швейцария · 1 центр

• Geneva University Hospitals — Geneva

Идентификаторы

NCT: NCT05606523 · 2022-00820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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