Tracking and predicting chemotherapy-related nerve damage in children with acute lymphoblastic leukemia
Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 173 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Zhengzhou, Henan and 2 other locations) |
| Trial ID | NCT07326930 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Zhengzhou, Henan and 2 other locations
- 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
- Principal investigator: Ka Yan Ho — The Hong Kong Polytechnic University
- Study coordinator: Ka Yan Ho, PhD
- Email: kyeva.ho@polyu.edu.hk
- Phone: 852-27666417
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.