The primary objective of this study is to investigate the course of plasma- and urinary levels of different carnitine-esters during IV administration of oxaliplatin.
ID
Source
Brief title
Condition
- Other condition
- Protein and amino acid metabolism disorders NEC
Synonym
Health condition
Carnitine metabolisme en excretie, deficiëntie, interactie met chemotherapie (oxaliplatin)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The entire carnitine spectrum in plasma will be measured using a precursor ion
scan. Urinary analysis will be done to measure the concentration of L-carnitine
in urine.
Secondary outcome
Not applicable
Background summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting
side effect of cytotoxic agents that can lead to decreased quality of life and
suboptimal treatment, which can lead to decreased survival. Currently, there
are no effective prophylactic and therapeutic options available. Research has
been done to study the effect of carnitine, but results are contradictory
probably due to severe heterogeneity between different studies and inadequate
administration of carnitine. We hypothesize that depletion of carnitine occurs
during infusion of oxaliplatin, due to increased renal loss. This might
contribute to the development of CIPN.
Study objective
The primary objective of this study is to investigate the course of plasma- and
urinary levels of different carnitine-esters during IV administration of
oxaliplatin.
Study design
A prospective observational study will be performed.
Study burden and risks
Risks of participation in this study are limited, since only blood is drawn and
urine is collected. Drawing of blood occurs a lot in daily practice, and
despite the fact that complications are known, occurrence is rare.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
1. Written informed consent
2. Age >18 years
3. Start treatment with oxaliplatin-based chemotherapy
4. Understanding the Dutch language
Exclusion criteria
1. Patients with known primary carnitine deficiency (congenital)
2. Patients on haemodialysis or peritoneal dialysis
3. Patients with epilepsy
4. Current treatment with valproic acid or zidovudine
5. Current use of carnitine supplements or use of carnitine supplements in the past 3 months
6. Pre-existent neuropathy or comorbid disorder causing neuropathy
7. Previous treatment with neurotoxic chemotherapy
8. Participation in an intervention study on CIPN (e.g. Frozen Gloves)
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 | NL65037.015.18 |