Back to Trials
NCT04786977RecruitingAccepts Healthy Volunteers

Physiologic Measure of VIPN

Children's National Research Institute

Start Date

9/20/2021

Completion Date

12/1/2027

Summary

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

Age Range: 6 years to 18 years

Inclusion Criteria: * 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. Exclusion Criteria: * have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.

Interventions

OTHER

No Intervention, Observational Study

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Locations

Children's National Health System

Washington D.C., District of Columbia 20010

United States