NCT07326930 Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia
| NCT ID | NCT07326930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Acute Lymphoblastic Leukemia ALL |
| Study Type | OBSERVATIONAL |
| Enrollment | 173 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2026-01-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 173 participants in total. It began in 2025-06-02 with a primary completion date of 2026-01-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Chemotherapy induced peripheral neuropathy was assessed at one week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4 (T5), two weeks after T5 (T6), two weeks after T5 (T7). Patients' demographic and clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy are obtained at baseline.
Eligibility 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.
Contact & Investigator
Ka Yan Ho
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT07326930 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Acute Lymphoblastic Leukemia ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07326930 currently recruiting?
Yes, NCT07326930 is actively recruiting participants. Contact the research team at kyeva.ho@polyu.edu.hk for enrollment information.
Where is the NCT07326930 trial being conducted?
This trial is being conducted at Zhengzhou, China, Shanghai, China, Shenzhen, China.
Who is sponsoring the NCT07326930 clinical trial?
NCT07326930 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Ka Yan Ho at The Hong Kong Polytechnic University. The trial plans to enroll 173 participants.
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