The first goal of this clinical trial is to assess the feasibility of transcutaneous acupoints electrical stimulation (TAES) on children with acute lymphoblastic leukemia (ALL). The second goal of this clinical trial is to evaluate the preliminary effectiveness of TAES on subject chemotherapy induced peripheral neuropathy (CIPN) symptoms severity, physical function, psychological distress, and quality of life at postintervention and at 1-, and 3-month follow-up postintervention. The main questions it aims to answer are: 1. What is the feasibility of implementing TAES for children with ALL, as measured by the eligibility rate, consent rate, randomization rate etc.? 2. Does TAES can improve CIPN symptoms severity, physical function, psychological distress, quality of life in children with ALL compared with sham control group? This proposed research is designed to conduct a two-arm RCT comparing TAES to sham TAES in children with ALL. Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in sham control group will follow the same protocol as the TEAS treatment but with 0 mA, 0 Hz TAES. These two groups will be provided with a leaflet containing self-help materials for CIPN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
Transcutaneous Acupoints Electrical Stimulation (TAES) is a kind of physical therapy that use electric current through the electrodes placed on the surface of acupoints to produce clinical effects in the human body.
It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.
The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
Zhengzhou, China
Feasibility measure - Screening rate
The number of participants being screened divided by the number of participants available for screening
Time frame: Baseline
Feasibility measure - Eligibility rate
The number of eligible participants divided by the number of screened participants.
Time frame: Baseline
Feasibility measure - Recruitment rate
The number of eligible participants who consent to join divided by the number of eligible participants
Time frame: Baseline
Feasibility measure - Randomization rate
The number of consented participants being randomized divided by the number of consented participants
Time frame: Baseline
Feasibility measure - Attendance rate
The number of participants in the experimental group and control group who complete the intervention divided by the number of participants randomized into the group
Time frame: immediately after intervention (T1)
Feasibility measure - Attrition rate
The number of participants who drop out divided by the number of participants randomized.
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Feasilibility measure - Adverse events
It will be denoted as the number of adverse events reported by the participants during the study period.
Time frame: During the study period including 8-week intervention and 3 months follow-up
CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
To evaluate the severity of CIPN. The Pediatric Chemotherapy-Induced Neuropathy scale contains 13 items, with eight items to rate CIPN symptoms in the hands and feet and five items to rate the difficulty of performing functional tasks. The total score ranges from 0 to 65 with higher scores indicating more severe CIPN.
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical functioning - Timed Up and Go test
Timed Up and Go test (TUG) will be used to evaluate the physical function in children with ALL.
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical functioning - 30-second sitting-rising test
30-second sitting-rising test will be used to evaluate the physical function in children with ALL.
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical functioning - grip strength
Handheld grip strength meter will be used to evaluate the physical function in children with ALL.
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Psychological distress
National Comprehensive Cancer Network (NCCN) distress thermometer will be used to evaluate the psychological distress of children with leukemia. It included two parts: one is a single-item DT screening tool using an 11-point visual scale for respondents to rate their level of subjective distress from 0 (no distress) to 10 (extreme distress). A cut off value ≥4 was recommended to indicate a distressed patient; another is a 40-items problem list to identify potential sources of distress including practical, family, emotional, physical, and spiritual distress.
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Quality of life outcome
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Pediatric Quality of Life Inventory version 3.0 cancer module (PedsQL 3.0 cancer module) will be used to evalute the quality of life for children with leukemia. The scale score was the average of the total item scores, with higher scores representing better quality of life.
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)