Perifere neuropathie als gevolg van vincristine bij kinderen met leukemie: een vergelijking van twee toedieningsvormen

Reducing vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia (ALL) by one-hour infusions instead of bolus injections

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29651

Enrollment

Registered

2013-11-11

Start date

2014-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute lymphoblastic leukemia Peripheral neuropathy Vincristine Chemotherapy

Interventions

Group A: patients receiving all VCR administrations by bolus injections ("push injections"). Group B: patients receiving all VCR administrations by one-hour infusions.

Eligibility

Inclusion criteria

Inclusion criteria: - diagnosed with pediatric ALL - treated according to the DCOG ALL-11/ALL-12 protocol (medium and high risk patients)

Exclusion criteria

Exclusion criteria: - younger than 2 years or older than 18 years at time of diagnosis - not able to comply with scheduled follow-up meausurements - mentally retarded - a known history of peripheral neuropathy or other pre-existing neurologic conditions before ALL diagnosis. - patients whose parents are unable to communicate in the Dutch language.

Design outcomes

Primary

Measure	Time frame
Peripheral neuropathy	—

Secondary

Measure	Time frame
- Quality of life - Costs - Therapeutic effectiveness - Pharmacokinetics - Genotyping	—

Contacts

Public ContactM.H. Berg, van den

P.O. box 7057

mh.vandenberg@vumc.nl+31 (0)20 4446021

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)