drugset / Trial / NCT01506453

Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)

NCT01506453

Phase 2 Completed 51 enrolled St. Jude Children's Research Hospital
RandomizedParallel-groupTriple-blindSupportive care

Summary

Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and scheduling regimens, and with varying measures of success. The hypothesis of the study is that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during treatment for ALL on the Total XVI protocol (or for those being treated "as per TOTXVI protocol"), as measured by two outcome measures: the daily dose of morphine used as needed for pain in addition to either gabapentin or placebo, as randomized, and the pain scores assessed daily.

Timeline

Start
2012-01-24
Primary completion
2018-01-02
Completion
2018-01-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gabapentin Small molecule 20 mg/kg Oral