Measuring nerve damage in children receiving chemotherapy
Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents
This study is testing a new way to measure nerve damage in children and teens with leukemia who are getting a chemotherapy drug called vincristine, to see if it helps catch problems earlier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT04786977 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a novel physiologic endpoint to assess vincristine-induced peripheral neuropathy (VIPN) in children and adolescents. By utilizing a new technology, the study seeks to provide a more sensitive and objective evaluation of VIPN, potentially allowing for earlier detection and monitoring of this condition. The study will enroll patients aged 6-18 who are receiving vincristine during the Delayed Intensification phase of treatment for acute lymphoblastic leukemia (ALL). Investigators will assess neuropathy using specific measures at each study visit to inform a neuropathy index.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 6-18 who are currently receiving vincristine as part of their cancer treatment.
Not a fit: Patients with eye pathology that prevents pupillometry, those who are hemodynamically unstable, or pregnant individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of chemotherapy-induced nerve damage, enhancing the quality of life for young cancer patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in developing objective measures for neuropathy, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Washington D.C., District of Columbia
- Children's National Health System — Washington D.C., District of Columbia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.