Measuring nerve damage in children receiving chemotherapy
Official title: Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents
Run by Children's National Research Institute · NCT04786977 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | September 20, 2021 |
| Main results expected | May 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT04786977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with eye pathology that prevents pupillometry, those who are hemodynamically unstable, or pregnant individuals may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies have shown promise in developing objective measures for neuropathy, suggesting potential for success.
Who can join: the full rules
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 it's running
-
Children's National Health System
Washington D.C., District of Columbia, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling
This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.
-
SIR2501 plus Paclitaxel for solid tumors
This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.
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Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors
This trial tests whether a gentle brain stimulation method (tDCS) can help reduce numbness, tingling, and pain from CIPN in cancer survivors who are not currently in treatment.
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Self-applied ear vagus nerve stimulation for chemotherapy-induced neuropathy
Researchers are testing a small, at-home device that you wear on the ear to see if it eases nerve pain from chemotherapy.
-
Blood extracellular vesicles to detect chemotherapy-related nerve damage.
We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.
-
Virtual LASO-3 diet program to ease chemotherapy-related numbness and tingling
This trial tests whether a virtual diet program that lowers added sugar and increases fiber and omega-3s can help cancer survivors who have numbness, tingling, or pain after neurotoxic chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.