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Clinical Trials in China / NCT07326930
Recruiting Observational

Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia

NCT07326930 · tracked via the Priya Life Science China tracker
Sponsor
The Hong Kong Polytechnic University
Phase
Observational
Started
2025-06-02
Last updated
2026-01-08

Condition(s) studied

Acute Lymphoblastic Leukemia ALL

Study 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

Sex
ALL
Min age
8 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale — 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 T6(T7)
    For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.

Trial sites (3)

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

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A Multimodal AI Agent for Ophthalmic Clinical Decision Support Starting soon

Other trials for the same condition

Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol Recruiting
Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia Recruiting
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07326930 on ClinicalTrials.gov ↗ ← All trials in China