About this trial
The purpose of this study is the development of a physiologic endpoint using a novel technology that would provide an objective, easy to use and more sensitive assessment of VIPN in children and adolescents. The ability to more easily detect and monitor VIPN, even before it is clinically evident, would facilitate optimizing the dosing of vincristine for maximal disease response while minimizing the risk of lifelong functional deficits affecting quality of life. This approach would also enable the development of specific therapies to minimize or eliminate the occurrence of VIPN in children and adolescents. This is a single site study that aims to develop a novel device to evaluate and characterize vincristine-induced neuropathic pain. The investigators will enroll patients with ALL following the Delayed Intensification (DI) phase of treatment. At each study visit, the investigators will evaluate the nPRD as well as the TNS-PV. The nPRD will inform the neuropathy index which will be used to compare to the TNS-PV. We anticipate a correlation between the two.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
6-18 years of age at the start of the study, are receiving vincristine in DI (clinical study population) and are willing and able to provide informed consent or assent to study participation.
Disqualifiers
have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.
Trial population
30 patients and 10 healthy volunteers will be enrolled for this study.
Trial design
Cohort
Prospective
Treatments tested in this trial
No Intervention, Observational Study
Other interventionNo Intervention
Treatment groups
Trial outcomes
Primary outcomes
Characterization of neuropathy index in patients with VIPN
The primary objective of this study is the characterization of the neuropathy index in VIPN patients in order to measure VIPN severity.
Secondary outcomes
Correlation of neuropathy index with the TNS-PV
The secondary objective is the correlation between the TNS-PV and the neuropathy index.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.