Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
Overview[ - collapse ][ - ]
Purpose | 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, 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. |
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Condition | Acute Lymphoblastic Leukemia Neuropathy Neuropathic Pain |
Intervention | Drug: gabapentin Drug: placebo |
Phase | Phase 2 |
Sponsor | St. Jude Children's Research Hospital |
Responsible Party | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier | NCT01506453 |
First Received | January 4, 2012 |
Last Updated | December 19, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 4, 2012 |
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Last Updated Date | December 19, 2013 |
Start Date | January 2012 |
Estimated Primary Completion Date | January 2016 |
Current Primary Outcome Measures | Daily total dose of oral morphine (mg/kg/day). [Time Frame: Daily beginning day 1 for a maximum of 21 days.] [Designated as safety issue: No]A quantity measured by pill count and/or adherence interview |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) |
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Official Title | Therapeutic Interventions For Peripheral Neuropathy/Neuropathic Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) On Total XVI Protocol |
Brief 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, 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 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. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care |
Condition |
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Intervention | Drug: gabapentin 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. Other Names: Treatment ArmDrug: placebo 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 Names: Placebo Arm |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 80 |
Estimated Completion Date | January 2016 |
Estimated Primary Completion Date | January 2016 |
Eligibility Criteria | Inclusion Criteria: - Participant is enrolled on Total XVI - 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: 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 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. |
Gender | Both |
Ages | 1 Year |
Accepts Healthy Volunteers | No |
Contacts | Contact: Doralina Anghelescu, MD 866-278-5833 info@stjude.org |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01506453 |
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Other Study ID Numbers | TINALL |
Has Data Monitoring Committee | No |
Information Provided By | St. Jude Children's Research Hospital |
Study Sponsor | St. Jude Children's Research Hospital |
Collaborators | Not Provided |
Investigators | Principal Investigator: Doralina Anghelescu, MD St. Jude Children's Research Hospital |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
St. Jude Children's Research Hospital | Memphis, Tennessee, United States, 38105 Contact: Doralina Anghelescu, MD | 866-278-5833 | info@stjude.orgPrincipal Investigator: Doralina Anghelescu, MD Recruiting |
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