An interventional study of Transcutaneous Acupoints Electrical Stimulation (TAES) and No intervention: sham TAES in Chemotherapy Induced Peripheral Neuropathy (CIPN), sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in China. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
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:
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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention for TAES group will conduct 2 times per week, total 8 weeks with covering 16 sessions. The intervention will be delivered by a registered nurse with qualified TCM nurse certification. Four bilateral acupoints - Hegu, Shousanli , Zusanli, and Chongyang will be choosen. TAES will be deliveried by electronic acupunture treatment instrument with low frequency. Each session lasts for 60 minutes.
Behavioral: Transcutaneous Acupoints Electrical Stimulation (TAES)
We will adopt a sham control for participants in the sham control group with the same frequency, duration and procedures as the TAES in the experimental group. However, only electrodes will be attached on the four bilateral acupoints, but without any electrical stimulation.
Other: No intervention: sham TAES
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.
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
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)
Plan to share: No
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The Hong Kong Polytechnic University