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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-02

Study Completion Date

2026-01-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia ALL

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No