Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia; Neuropathy; Neuropathic Pain
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neuralgia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Patients with ALL on Total XVI ((or for those being treated "as per TOTXVI protocol") who
      experience NP/PN after specific doses of vincristine are eligible to enroll in the study as
      soon as the diagnosis of NP/PN related to VCR is established. The qualifying doses of
      vincristine have been selected because they fall in the schedule of weekly vincristine doses
      as per Total XVI, and 2 additional weekly vincristine doses are anticipated according to the
      protocol. Participants will be randomized to receive gabapentin or placebo upon enrollment.
      Morphine will be available to both groups as needed for pain at any time on the study. At the
      time of enrollment, and daily thereafter until completion of the study drug, data will be
      collected for pain assessment, and the daily dose of oral morphine used will be collected.
      Data regarding the pain type, quality, and location, as well as treatments used to manage
      pain will be assessed on a daily basis for the diagnostic event and for the period following
      the next two administrations of VCR treated with the study drug.

      Primary Objective: To assess the analgesic efficacy of gabapentin in controlling VCR-related
      NP/PN in participants with ALL, by comparing the morphine daily dose (mg/kg/day) used to
      control NP/PN as a primary or a rescue regimen in the gabapentin vs. placebo groups.

      Secondary Objective: To compare the pain scores in the gabapentin and placebo groups as
      recorded by pain score right now and pain score average for previous 24 hours.
    

Intervention name(s): gabapentin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation.; Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment.
Other intervention name(s): Treatment Arm; Placebo Arm
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Acute Lymphoblastic Leukemia; Neuropathy; Neuropathic Pain; Vincristine; TOTAL XVI Protocol