Vincristine-induced peripheral neuropathy in children with childhood cancer: comparing one-hour infusions with short-term infusions (the VINCA-study)

Completed

Conditions: childhood cancer
Pediatric oncology
10024324
10027655

Registration Number: NL-OMON47569

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 58

Inclusion Criteria

• age between 2 and 19 years.
• treated for cancer according to a treatment protocol which includes at least
6 administrations of VCR of which 4 are administered within a maximum period
of maximum 6 weeks (these are acute lymphoblastic leukemia, nephroblastoma,
Hodgkin lymphoma, low-grade glioma, medulloblastoma and rhabdomyosarcoma)
• diagnosed with a cancer diagnosis of which the incidence in the Netherlands
is of more than 5 newly diagnosed patients per year; within the Netherlands
• written informed consent.;

Exclusion Criteria

• patient or parent refusal
• history of peripheral neuropathy or other pre-existing or disease- related
sensory or motor neurologic conditions
• pre-existing severe mental retardation;
• having parents/ guardians who are unable to communicate in the Dutch
language.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the study is peripheral neuropathy (PNP). PNP will be<br /><br>evaluated by using the NCI Common Terminology Criteria for Adverse Events<br /><br>(CTCAE), version 4.03. This is a widely-used scoring method for reporting<br /><br>adverse events in clinical trials. PNP will be evaluated by scoring peripheral<br /><br>motor neuropathy, peripheral sensory neuropathy, neuralgia (pain), and<br /><br>constipation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include quality of life, costs (direct medical costs,<br /><br>direct non-medical costs, and indirect costs), treatment efficacy,<br /><br>pharmacokinetic measures (claerance, VCR plasma concentrations and the primary<br /><br>metabolite), and genetic polymorphisms known or suspected to be associated with<br /><br>VCR-induced to PNP or VCR resistance. In addition, a recently developed<br /><br>neuropathy measurement tool (ped-mTNS) will be used to assess PNP.</p><br>