Improving Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: A Study of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure Interventions

Effectiveness of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure on Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: a Single Blind Randomized Controlled Study

The goal of this clinical trial is to compare the effectiveness of Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) on subject CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in Children with Leukemia.

The main questions it aims to answer are:

1. Does TAES and AA can improve CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in children with Leukemia compared with self-management control group?
2. Does TAES yield improvements in CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes that are comparable to those achieved through AA in children with leukemia?

This proposed research is designed to conduct a three-arm RCT comparing TAES, AA to usual care in children with leukemia.

Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in AA group will receive 8 weeks on four acupoints. Subjects in self-management control group will receive usual care they will receive from the hospital. These three 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: Other: No intervention; Behavioral: Transcutaneous Acupoints Electrical Stimulation (TAES); Behavioral: Auricular Acupressure (AA)

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Yan Ho, PhD; Phone Number: +85227666417 +85254844554; Email: kyeva.ho@polyu.edu.hk

Study Locations

• China
  • Shanghai, China
    • Shanghai Children Medical Center
    • Contact: Meng Xue He, PhD; Phone Number: (86)15702140512; Email: hemx0321@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• age between 8 and 17 years old
• diagnosed with leukemia
• 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, liver or renal function
• contraindications to TEAS or auricular acupressure: 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Acupoints Electrical Stimulation (TAES); The intervention for TAES group will last 8 weeks, conducting 2 times per week, total covering 16 sessions. The intervention will be delivered 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 is 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.
Experimental: Auricular Acupressure (AA); The AA subjects received auricular acupressure three times a day for two days every week for 8 weeks, total covering 16 sessions. Four acupoints including Shenmen (TF4), sympathetic (AH6a), fingers (SF1) and toes (AH2) will be choosen. A small piece of adhesive tape with vaccaria seed will be taped onto each selected auricular acupoint on a subject's ear.	Behavioral: Auricular Acupressure (AA); Auricular acupressure (AA) is a non-invasive therapy rooted in Traditional Chinese Medicine (TCM) that involves applying pressure to specific acupoints on the ear using Vaccaria seeds.
Placebo Comparator: Self-Managed control group; Subjects shall receive leaflet containing self-help materials for CIPN which they can conduct by themself (self-management) and continue to receive their usual care from the hospital.	Other: No intervention; No intervention

What is the study measuring?

Primary 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory function outcomes	Touch sensation were measured using monofilament examination with the best of both 2 trials on each side averaged.	Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Sensory function outcomes	Vibration sensation were measured using a 128 Hz tuning fork, with the best of both 2 trials on each side averaged.	Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function	Timed Up and Go test (TUG) will be used to evaluate the motor and physical function in children with leukemia.	Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function	30-second sitting-rising test will be used to evaluate the motor and physical function in children with leukemia.	Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function	Handheld grip strength meter will be used to evaluate the motor and physical function in children with leukemia.	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)
Physical symptoms	The therapy-related symptom checklist for children (TRSC-C) Chinese version will be used to assess the physical symptoms severity. The total TRSC-C score ranges between 0 to 120, with higher scores indicating greater severity of symptoms.	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)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 8, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: children; Leukemia; chemotherapy induced peripheral neuropathy; Auricular Acupressure; Transcutaneous Acupoints Electrical Stimulation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia
• Other Study ID Numbers: TAES and AA to treat CIPN

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