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The effect of intravenous L-carnitine supplementation during oxaliplatin based chemotherapy on blood- and urinary levels of carnitine

The effect of intravenous L-carnitine supplementation during oxaliplatin based chemotherapy on blood- and urinary levels of carnitine - Pilot carnitine supplementation during oxaliplatin infusion

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48693
Enrollment
10
Registered
2019-11-06
Start date
2019-11-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carnitine metabolisme, excretie, deficiëntie, interactie met chemotherapie (oxaliplatin) Deficiency/lack of/reduction of concentration of carnitine (an amino acid or half-vitamin) during/caused by treatment with chemotherapy (oxaliplatin)

Interventions

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.

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Age >18 years 3. Start treatment with oxaliplatin-based chemotherapy 4. Understanding the Dutch language

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)