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Blood- and urinary levels of different carnitine-esters during administration of oxaliplatin based chemotherapy


- candidate number29097
- NTR NumberNTR7319
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jul-2018
- Secondary IDsABR (CCMO) NL65037.015.18
- Public TitleBlood- and urinary levels of different carnitine-esters during administration of oxaliplatin based chemotherapy
- Scientific TitleBlood- and urinary levels of different carnitine-esters during administration of oxaliplatin based chemotherapy
- ACRONYM-
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedChemotherapy, Periferal neuropathy, Carnitine, Oxaliplatin chemotherapy
- Inclusion criteria 1. Written informed consent
2. Age >18 years
3. Start treatment with oxaliplatin-based chemotherapy
4. Understanding the Dutch language
- Exclusion criteria1. 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)
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2018
- planned closingdate1-sep-2019
- Target number of participants10
- InterventionsNo intervention/controls.
For measurements: drawing blood and collecting urine.
- 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.
- TimepointsDraw blood at baseline, 5 minutes, 60 minutes, 120 minutes and 180 minutes
Collect urine at baseline and 180 minutes
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. L. Verdonschot
- CONTACT for SCIENTIFIC QUERIESDrs. L. Verdonschot
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Alfasigma BV Nederland
- Publications
- Brief summaryChemotherapy-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.
- Main changes (audit trail)
- RECORD1-jul-2018 - 9-jul-2018


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