Physiologic Measure of VIPN

Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04786977

Enrollment

Registered

2021-03-08

Start date

2021-09-20

Completion date

2027-12-01

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Peripheral Neuropathy

Brief 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.

Interventions

OTHERNo Intervention, Observational Study

No Intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Characterization of neuropathy index in patients with VIPN	1 Year	The primary objective of this study is the characterization of the neuropathy index in VIPN patients in order to measure VIPN severity.

Secondary

Measure	Time frame	Description
Correlation of neuropathy index with the TNS-PV	1 Year	The secondary objective is the correlation between the TNS-PV and the neuropathy index.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026