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.
Study Type
OBSERVATIONAL
Enrollment
40
No Intervention
Children's National Health System
Washington D.C., District of Columbia, United States
RECRUITINGCharacterization 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.
Time frame: 1 Year
Correlation of neuropathy index with the TNS-PV
The secondary objective is the correlation between the TNS-PV and the neuropathy index.
Time frame: 1 Year
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