Physiologic Measure of VIPN

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04786977
• Other study ID #: Pro00015693
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• No Intervention, Observational Study
No Intervention

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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