Safety of a methionine-low diet in patients with AML
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The safety will be analysed by the occurrence of (S)AE
Secondary outcome
The effectiveness will be measured in the level of leukaemia blasts and the
methionine-levels in plasma.
Background summary
Leukemia cells have an increased need for methionine. Depletion of methionine
in vitro is toxic to leukemia cells but not to healthy cells. Previous phase I
and II studies show little to no side effects from a lmethionin-low diet in
humans. In this study, we aim to explore the safety and effectiveness of a
methionine-low diet in patients with AML
Study objective
Safety of a methionine-low diet in patients with AML
Study design
Human experimental study (fase 1 pilot)
Intervention
A Methionine-low diet, first by tubefeeding, alter by regulare oral
foodproducts
Study burden and risks
Aspiration pneumonia in tube feeding
Bleeding and pain from bone marrow puncture and blood sampling
Weight loss and malnutrition
Limitation in own diet
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Acute myeloid leukemia
Adult
Exclusion criteria
Acute promyolocytic leukemia
medical indication for other diet
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73144.042.20 |