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

NCT07326930 | Recruiting

• 1 other identifier: CIPN trajectories
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Lymphoblastic Leukemia ALL

Keywords

Chemotherapy induced peripheral neuropathy; tracjectory; predictor; children; acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale

  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.

  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)

Other Outcomes (7)

• The therapy-related symptom checklist for children (TRSC-C)

  Baseline

• Screening tool for the assessment of malnutrition in pediatrics, STAMP

  Baseline

• National Comprehensive Cancer Network (NCCN) distress thermometer (DT)

  Baseline

Study Arms (1)

Questionnaire

Participants will complete chemotherapy induced peripheral neuropathy, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy scales.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with acute lymphoblastic leukemia are recruited from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (3)

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

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ka Yan Ho

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Yan Ho, PhD

CONTACT

852-27666417; kyeva.ho@polyu.edu.hk

Ting MAO

CONTACT

852-54844554; tingting.mao@connect.polyu.hk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: June 2, 2025
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)