Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia ALL. Basic parameters: 8 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study
Overview
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.
Primary outcome measures
- Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale [Time frame: 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 3 centers
- The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, — Zhengzhou
- Shanghai Children's Medical Center — Shanghai
- Shenzhen Children's Hospital — Shenzhen
Identifiers
NCT: NCT07326930 · CIPN trajectories