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
Intervention: gabapentin; placebo
Intervention description: 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.
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; Neuropathy; Neuropathic Pain; Vincristine; TOTAL XVI Protocol

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is enrolled on Total XVI or who are being treated "as per TOTXVI protocol"

          -  Participant is 1 year of age or older

          -  Participant has symptoms of NP/PN with onset no more than 7 days after one of the
             following vincristine doses ± 3 days: protocol week 1, week 2 (induction), week 7
             (reinduction I), or week 17 (reinduction II).

          -  Patient is expected to receive 2 doses of vincristine in weekly intervals as outlined
             by the Total XVI protocol (or for those being treated "as per TOTXVI" protocol) while
             on study drug (i.e. no known dosage reductions or planned missed doses).

        Participant is able and willing to take oral medications.

        Exclusion Criteria:

          -  Previous participation in this study

          -  Participant is receiving gabapentin for another indication at the time of diagnosis of
             NP/PN or has received gabapentin previously.

          -  Pregnancy. Female participants of childbearing potential must have documented negative
             urine or serum pregnancy test result not older than 7 days. Male patients with
             reproductive potential will be counseled not to procreate during the study.

          -  Impaired renal function: decreased eGFR (<60ml/min/1.73m^2 as estimated by the revised
             Schwartz equation)

          -  Participant has allergy or other contraindication for either morphine or gabapentin
             therapy.

          -  Inability or unwillingness of research participant or legal guardian/representative to
             give written informed consent.