Clinical trial Recruiting at 3 sites Observational Ages 8 to 17

Tracking and predicting chemotherapy-related nerve damage in children with acute lymphoblastic leukemia

Official title: Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study

Run by The Hong Kong Polytechnic University · NCT07326930 · Data updated 2026-11-12

Researchers will track how vincristine-related nerve damage develops over time in children (ages 8–17) with acute lymphoblastic leukemia and try to identify factors that predict different symptom patterns.

More Acute Lymphoblastic Leukemia (ALL) trials

Quick facts

Study typeObservational
Ages8 Years to 17 Years
SexAll
Enrollment173 (estimated)
SponsorThe Hong Kong Polytechnic University
Academic / other
Drugs / interventionschemotherapy
Locations3 sites (Zhengzhou, Henan and 2 other locations)
StatusRecruiting
StartedJune 2, 2025
Main results expectedJanuary 7, 2026
Study endsJanuary 7, 2026
Registry record updatedJanuary 8, 2026
Trial IDNCT07326930 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 8–17 years with a diagnosis of acute lymphoblastic leukemia who will receive vincristine per the CCCG-ALL-2020 protocol, are cognitively able to report symptoms, and whose parents and the child provide informed assent/consent.

Probably not a fit

Children with preexisting neuropathy from other diseases, neuromuscular disorders, CNS or secondary cancers, severe organ failure, or those enrolled in other experimental interventions altering neuropathy risk are unlikely to gain benefit from this observational project.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective longitudinal observational study of children with acute lymphoblastic leukemia who receive vincristine according to the CCCG-ALL-2020 protocol. Peripheral neuropathy symptoms are measured repeatedly at standardized times after successive vincristine doses (one week after the 1st–4th doses, then at two-week intervals up to the seventh follow-up). Baseline data including demographics, clinical features, physical symptoms, nutrition, psychological distress, sleep quality, physical activity, social support, and coping strategies are collected. Trajectory modeling will be used to identify distinct symptom course patterns and examine which baseline factors predict membership in those trajectories.

Why it matters

Potential benefit: If successful, the results could help clinicians identify children at higher risk for prolonged or severe neuropathy and tailor monitoring or supportive care to reduce long-term symptoms.

How similar studies have gone: Prior research has documented vincristine-induced neuropathy and some risk factors in children, but detailed longitudinal trajectory modeling of symptom courses in this specific population remains relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* diagnosed with acute lymphoblastic leukemia
* aged from 8 to 17 years
* will receive vincristine according the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020)
* conscious with sufficient cognitive abilities to understand and express their physical state and psychological feelings accurately
* written informed assent is obtained from the children and their parents for their participation in the study

Exclusion Criteria:

* participating other experimental trials, such as electrical stimulation, exercise therapy may improve CIPN symptoms.
* with severe complications, including but not limited to significant heart, brain, or lung function failure.
* had peripheral neuropathy symptoms caused by other diseases like genetic diseases, spinal cord injury.
* had neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy).
* had central nervous system cancer or secondary cancer.
* had multiple treatment like radiotherapy.

Where it's running

  • The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital,
    Zhengzhou, Henan, China
    Recruiting
  • Shanghai Children's Medical Center
    Shanghai, China
    Recruiting
  • Shenzhen Children's Hospital
    Shenzhen, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.