No registrations found.
ID
Source
Brief title
Health condition
Carnitine metabolism and carnitine deficiëncy
Interaction of oxaliplatin chemotherapy with carnitine
Chemotherapy induced peripheral neuropathy
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To evaluate the course of plasma- and urinary carnitine levels of all carnitine esters during the first cycle of treatment with oxaliplatin-based chemotherapy:
Plasma and urinary concentrations of different carnitine-esters before, during and right after administration of oxaliplatin-based chemotherapy
Secondary outcome
- To gain insight in patient factors such as lifestyle, diet and comorbidities that can influence baseline carnitine levels in cancer patients:
Length and body weight, information about diet, nicotine- and alcohol consumption habits, comorbidities, type of cancer, cancer stage, chemotherapy regimen, history of chemotherapy use.
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. 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. A prospective observational study will be performed. All patients planned to start with oxaliplatin-based chemotherapy at the Máxima Medical Centre in Veldhoven/Eindhoven are eligible for participation in this study.
Study objective
We hypothesize that depletion of carnitine occurs during infusion of oxaliplatin, due to increased renal loss. This secondary carnitine deficiency may contribute to the development of CIPN.
Study design
Draw blood at baseline, 5 minutes, 60 minutes, 120 minutes and 180 minutes
Collect urine at baseline and 180 minutes
Intervention
No intervention/controls.
For measurements: drawing blood and collecting urine.
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 |
|---|---|
| NTR-new | NL7114 |
| NTR-old | NTR7319 |
| Other | NL65037.015.18 : ABR (CCMO) |