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‘Effect of Faecal Transplantation on Satiety, Sarcopenia, Inflammation and Chemotherapy Toxicity in patients with Metastasized Oesophageal and Gastric Cancer’


- candidate number24676
- NTR NumberNTR5984
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2016
- Secondary IDsMETC 2016_025 
- Public Title‘Effect of Faecal Transplantation on Satiety, Sarcopenia, Inflammation and Chemotherapy Toxicity in patients with Metastasized Oesophageal and Gastric Cancer’
- Scientific Title‘Effect of Faecal Transplantation on Satiety, Sarcopenia, Inflammation and Chemotherapy Toxicity in patients with Metastasized Oesophageal and Gastric Cancer’
- ACRONYMTRANSIT study
- hypothesisWe postulate that faecal microbiota transplantation (FMT) from obese donors in patients with cancer can improve satiety (appetite) and subsequently nutritional status. Secondly, FMT might restore the gut barrier function and hence reduce systemic inflammatory tone.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Gastric carcinoma, Microbiotica
- 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
- Meeting the criteria for sarcopenia, using computed tomography (CT)-scan: the L3 muscle area surfaces will be normalized for patient height to calculate the L3 muscle index and expressed in cm2/m2. The cutoff values used for sarcopenia are 52.4 cm2/m2 for men and 38.5 cm2/m2 for women, based on the method of Prado et al1
- Meeting the International Classification of Functioning, Disability and Health (ICF)28, WHO 1, 2 or 3.
- Stable medication use, all subjects use PPI.
- Subjects should be able and willing to give informed consent
- Exclusion criteria- Smoking, XTC, amphetamine or cocaine abuse
- Alcohol abuse (>3/day)
- Cholecystectomy
- HIV infection with a CD4 count < 240
- Chronic nausea, altered taste sensation, swallowing difficulties or mechanical obstruction due to the malignancy.
- History of neurological disease or psychiatric disorder.
- Patients with diabetes mellitus (there are several studies indicating that a high level of NLR may reflect ongoing vascular inflammation and play an important role in the pathophysiology of DM and even prediabetes) 29.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2016
- planned closingdate1-aug-2018
- Target number of participants16
- InterventionsFMT
- Primary outcomeEffect 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 outcomeEffect of fecal transplantation on:
1. Sarcopenia (measured by CT-scan).
2. Body composition (BIA)
3. Systemic inflammation and gut barrier function (CRP, plasma interleukins/LPS binding protein levels and fecal calprotectin) in relation to energy metabolism as measured by resting energy expenditure (REE).
4. Chemotherapy toxicity, graded with the Common Terminology Criteria for Adverse Events (CTCAE)11
5. Treatment response measured by CT-scan at baseline and after the first 3 cycles of chemotherapy (week 12).
6. Overall survival (defined as the number of days of survival after PA diagnosis).
- Timepoints0,4, and 12 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summarySarcopenia, the loss of skeletal muscle mass and strength, is associated with increased risk of chemotherapy toxicity and poor overall survival in patients with cancer due to poor nutritional status. Previous animal data suggest that faecal microbiota transplantation (FMT) from obese donors can drive weight gain. We will thus study in cancer patients whether obese FMT improves sarcopenia, satiety (appetite) and subsequent nutritional status.
- Main changes (audit trail)
- RECORD21-jul-2016 - 26-sep-2016


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