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

Phase 2
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)
10013317
Registration Number
NL-OMON48693
Lead Sponsor
Maxima Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
10
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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The entire carnitine spectrum in plasma will be measured using a precursor ion<br /><br>scan. Urinary analysis will be done to measure the concentration of L-carnitine<br /><br>in urine.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable. </p><br>
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