The primary objective of this study is to evaluate the course of plasma- and urinary levels of carnitine and all carnitine esters during the first cycle of treatment with oxaliplatin-based chemotherapy and intravenous carnitine supplementation. The…
ID
Source
Brief title
Condition
- Other condition
- Lipid metabolism disorders
Synonym
Health condition
Carnitine metabolisme, 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 and can be prevented by infusion of
levocarnitine .
Study objective
The primary objective of this study is to evaluate the course of plasma- and
urinary levels of carnitine and all carnitine esters during the first cycle of
treatment with oxaliplatin-based chemotherapy and intravenous carnitine
supplementation. The secondary objective is to evaluate if the chosen route and
dose of carnitine supplementation are adequate to prevent a carnitine
deficiency.
Study design
An open pilot study will be performed.
Intervention
Patients will receive levocarnitine 2 gram intravenously, before start of the
oxaliplatin-based chemotherapy. Blood and urinary samples will be collected
during administration of the chemotherapy.
Study burden and risks
Risks of participation in this study are limited, since only blood is drawn and
an endogenous nutrient is infused. Drawing of blood occurs a lot in daily
practice, and despite the fact that complications are known, these are not
serious and occurrence is rare. Infusion of carnitine is generally considered
safe, with nausea and diarrhoea being the only known minor side effect. This
could also be caused by chemotherapeutics in this study, profylactic treatment
and supportive care will be supplied as usual care.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
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. No written informed consent
2. Patients with known primary carnitine deficiency (congenital)
3. Patients on haemodialysis or peritoneal dialysis
4. Patients with epilepsy
5. Current treatment with valproic acid or zidovudine
6. Current use of carnitine supplements or use of carnitine supplements
in the past 3 months
7. Pre-existent neuropathy or comorbid disorder causing neuropathy
8. Previous treatment with neurotoxic chemotherapy
9. Participation in an intervention study on CIPN (e.g. Frozen Gloves)
6. Current use of carnitine supplements or use of carnitine supplements in the
past 3 months, 7. Pre-existent neuropathy or comorbid disorder causing
neuropathy, 8. Previous treatment with neurotoxic chemotherapy, 9.
Participation in an intervention study on CIPN (e.g. Frozen Gloves)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2018-000485-11-NL |
| CCMO | NL66001.028.18 |