|- candidate number||24676|
|- NTR Number||NTR5984|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jul-2016|
|- Secondary IDs||METC 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’|
|- ACRONYM||TRANSIT study|
|- hypothesis||We 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) studied||Esophageal 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)
- 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2016|
|- planned closingdate||1-aug-2018|
|- Target number of participants||16|
|- Interventions||FMT |
|- Primary outcome||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||Effect 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
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).
|- Timepoints||0,4, and 12 weeks|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M. Nieuwdorp|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M. Nieuwdorp|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Sarcopenia, 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)|
|- RECORD||21-jul-2016 - 26-sep-2016|