Physiologic Measure of VIPN

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorChildren's National Research Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention, Observational Study

    Other intervention

    No Intervention

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: VIPN Patients1 intervention
Group B: Healthy Volunteers1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 Year

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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