‘Effect of Faecal Transplantation on Satiety, Sarcopenia, Inflammation and Chemotherapy Toxicity in patients with Metastasized Oesophageal and Gastric Cancer’
Recruiting
- Conditions
- patients with metastasized or locally advanced oesophageal or gastric cancer receiving standard first-line palliative chemotherapy (capecitabine/oxaliplatin).FMTmicrobiota
- Registration Number
- NL-OMON27424
- Lead Sponsor
- AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Male or female with metastasized or locally advanced oesophageal and/or gastric cancer receiving standard first-line palliative chemotherapy (capecitabine/oxaliplatin)
- Age between 30-70 years
Exclusion Criteria
- Smoking, XTC, amphetamine or cocaine abuse
- Alcohol abuse (>3/day)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of fecal transplantation (from healthy obese donors) on feceal microbiota composition in relation to satiety (questionnaires, biomarkers, ) and metabolism (REE ) in patients with metastasized or locally advanced oesophageal or gastric cancer receiving standard first-line palliative chemotherapy (capecitabine/oxaliplatin).
- Secondary Outcome Measures
Name Time Method Effect of fecal transplantation on:<br /><br>1. Sarcopenia (measured by CT-scan).<br /><br>2. Body composition (BIA)<br /><br>3. Systemic inflammation and gut barrier function (CRP, plasma interleukins/LPS<br>binding protein levels and fecal calprotectin) in relation to energy metabolism as<br>measured by resting energy expenditure (REE).<br /><br>4. Chemotherapy toxicity, graded with the Common Terminology Criteria for Adverse<br>Events (CTCAE)11<br /><br>5. Treatment response measured by CT-scan at baseline and after the first 3 cycles of<br>chemotherapy (week 12).<br /><br>6. Overall survival (defined as the number of days of survival after PA diagnosis).