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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27424

Enrollment

Registered

2016-07-21

Start date

2016-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with metastasized or locally advanced oesophageal or gastric cancer receiving standard first-line palliative chemotherapy (capecitabine/oxaliplatin). FMT microbiota

Interventions

FMT

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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).	—

Measure

Time frame

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 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).

—

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)