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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Acute Lymphoblastic Leukemia ALL

Study type: Observational

Funder types: Other

Identifiers

NCT07326930

CIPN trajectories

Details and patient eligibility

About

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.

Enrollment: 173 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

173 participants in 1 patient group

Questionnaire

Description:

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