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

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.
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
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	Pain scores right now [Time Frame: Daily beginning day 1 through a maximum of 21 days.] [Designated as safety issue: No]A score ranging from 0 to 10, measured by age appropriate validated pain scale Pain score during the previous 24 hours [Time Frame: Daily beginning day 1 through a maximum of 21 days] [Designated as safety issue: No]A score ranging from 0 to 10, measured by age appropriate validated pain scale

Descriptive Information[ + expand ][ + ]

Brief Title	Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
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	Acute Lymphoblastic Leukemia Neuropathy Neuropathic Pain
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)	Active Comparator: Gabapentin Active treatment arm. Placebo Comparator: Placebo Placebo arm.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
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
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 ][ + ]