Phase 2
Completed N=51
Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
Source: ClinicalTrials.gov NCT01506453 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Daily Total Dose of Oral Morphine (mg/kg/Day). — 0.38267; 0.27433; 0.43685; 0.31816 mg/kg/day
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Total Dose of Oral Morphine (mg/kg/Day). |
0.38267; 0.27433; 0.43685; 0.31816; 0.37281; 0.27961 | — |
| SECONDARY Pain Scores Right Now |
1.64000; 1.69565; 2.00000; 1.16667; 1.88000; 0.75000 | — |
| SECONDARY Pain Score During the Previous 24 Hours |
3.48000; 3.41667; 3.16000; 2.20833; 3.08000; 1.87500 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01506453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.