Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia

Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Chinese Children With Acute Lymphoblastic Leukemia: A Randomized Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Intervention / Treatment: Behavioral: Transcutaneous Acupoints Electrical Stimulation (TAES); Other: No intervention: sham TAES

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Yan HO; Phone Number: +85254844554; Email: kyeva.ho@polyu.edu.hk

Study Locations

• China
  • Zhengzhou, China
    • The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
    • Contact: Meng Meng Luo; Phone Number: 0371-65588251; Email: 1213347977@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age between 10 and 17 years old
• diagnosed with ALL
• received neurotoxic chemotherapy
• have developed score 9 or above CIPN symptoms according to Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
• able to communicate and read Chinese

Exclusion Criteria:

• receiving multiple cancer treatment
• had a diagnosis of cancer in the central nervous system cancer, cancer relapse or secondary cancer
• having other neuromuscular disorders, for example, traumatic brain injury and cerebral palsy
• having other systematic diseases that cause toxicity in the peripheral nervous system, such as sickle cell disease (SCD), Guillain-Barre ́ Syndrome (GBS), anterior cutaneous nerve entrapment syndrome (ACNES), obstetric brachial plexus injury (OBPI), type I diabetes mellitus, postherpetic neuralgia (PHN), peroneal nerve injury, and reflex sympathetic dystrophy (RSD)
• acupoints areas with injuries, wounds or allodynia
• participated in any other CIPN non-pharmacological intervention programme
• having any impaired bone marrow suppression
• contraindications to TEAS : such as having a pacemaker, skin infection, damage, or allergy to the electrodes
• suffering from mental illness or using antipsychotic drugs
• parents and children refused to give consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Acupoints Electrical Stimulation (TAES) group; 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); 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.
Sham Comparator: Sham control group; 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; It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measure - Screening rate	The number of participants being screened divided by the number of participants available for screening	Baseline
Feasibility measure - Eligibility rate	The number of eligible participants divided by the number of screened participants.	Baseline
Feasibility measure - Recruitment rate	The number of eligible participants who consent to join divided by the number of eligible participants	Baseline
Feasibility measure - Randomization rate	The number of consented participants being randomized divided by the number of consented participants	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	immediately after intervention (T1)
Feasibility measure - Attrition rate	The number of participants who drop out divided by the number of participants randomized.	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.	During the study period including 8-week intervention and 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: children; acute lymphoblastic leukemia; Chemotherapy induced peripheral neuropathy; transcutaneous acupoints electrical stimulation
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: Electrical stimulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No