About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Other outcomes
The therapy-related symptom checklist for children (TRSC-C)
TRSC-C is used to assess the participants' physcial symptoms. This checklist contains 30 items divided into 7 factors (1) nutrition-related, (2) psychosocial/ central nervous system (CNS), (3) oropharyngeal, (4) bone marrow toxicity/neuropathy, (5) skin/other toxicities, (6) neurotoxicities, and (7) respiratory/other symptoms. The total TRSC-C score is computed as the average of the symptom scores for all 30 symptoms. Higher scores indicating greater severity of symptoms
Screening tool for the assessment of malnutrition in pediatrics, STAMP
The STAMP is used to assess the nutritional status of participants. The nutritional risk is divided into low risk (0-1 points), moderate risk (2-3 points), and high risk (≥4 points) based on the total score (0-9 points).
National Comprehensive Cancer Network (NCCN) distress thermometer (DT)
The NCCN-DT was used to assess psychological distress among participants. A cut off value ≥4 for single-item DT screening tool is recommended to indicate a distressed patient.
A specific item - 'subjective sleep quality' from the Pittsburgh Sleep Quality Index scale, PSQI
A specific item - 'subjective sleep quality' from PSQI is used to assess the participants' sleep quality. Answer is coded into a 0-3 score for this item, with higher score reflect poor sleep quality.
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