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Trajectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Prospective Longitudinal Study
Led by The Hong Kong Polytechnic University · Updated on 2026-01-08
173
Participants Needed
3
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research aims to study the patterns and predictors of chemotherapy-induced peripheral neuropathy (CIPN) in children aged 8 to 17 years with acute lymphoblastic leukemia (ALL). The study uses a prospective longitudinal design to observe how CIPN develops over the course of chemotherapy treatment involving vincristine. Researchers also collect baseline data on patients' demographics, clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, social support, and coping strategies to identify factors linked to different CIPN trajectories. Participants will be assessed at multiple time points: one week after each of the first four vincristine doses, and then at two-week intervals following the fourth dose, up to seven total assessments. During these visits, children will complete questionnaires covering chemotherapy-induced peripheral neuropathy, physical symptoms, nutrition, psychological distress, sleep quality, physical activity, perceived social support, and coping strategies. This approach allows detailed tracking of symptom changes and potential influencing factors throughout chemotherapy. Children involved in the study will undergo regular evaluations using the Pediatric Chemotherapy-Induced Peripheral Neuropathy (P-CIN) scale at specified intervals after vincristine administration. The study also gathers comprehensive information through various scales and questionnaires to monitor the child's condition and well-being. Participation requires written assent from the child and consent from their parents, and the study is planned to run until January 2026, providing a thorough observation of neuropathy development during treatment.
CONDITIONS
Brief Title
Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute lymphoblastic leukemia
- Aged from 8 to 17 years
- Will receive vincristine according to the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020)
- Conscious with sufficient cognitive abilities to understand and express physical and psychological states accurately
- Written informed assent obtained from the child and their parents for participation
You will not qualify if you...
- Participating in other experimental trials such as electrical stimulation or exercise therapy aimed at improving chemotherapy-induced peripheral neuropathy symptoms
- Having severe complications including significant heart, brain, or lung function failure
- Having peripheral neuropathy symptoms caused by other diseases like genetic disorders or spinal cord injury
- Having neuromuscular diseases such as traumatic brain injury or cerebral palsy
- Having central nervous system cancer or secondary cancer
- Receiving multiple treatments like radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 12 weeks covering assessments one week after each of the first four uses of vincristine and follow-up assessments two weeks apart thereafter.
Participants complete questionnaires on chemotherapy-induced peripheral neuropathy, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support, and coping strategies.
7 questionnaire assessments aligned with vincristine treatment schedule
Trial Site Locations
Total: 3 locations
1
The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital,
Zhengzhou, Henan, China
Actively Recruiting
2
Shanghai Children's Medical Center
Shanghai, China
Actively Recruiting
3
Shenzhen Children's Hospital
Shenzhen, China
Actively Recruiting
Research Team
K
Ka Yan Ho, PhD
T
Ting MAO
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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