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

NCT07279818 | Not Yet Recruiting DMC

• 1 other identifier: TAES and AA to treat CIPN
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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?

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Keywords

Transcutaneous Acupoints Electrical Stimulation; Auricular Acupressure; chemotherapy induced peripheral neuropathy; Leukemia; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Sensory function outcomes

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Sensory function outcomes

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Motor and physical function

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Motor and physical function

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Motor and physical function

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

Study Arms (3)

Transcutaneous Acupoints Electrical Stimulation (TAES)

EXPERIMENTAL

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)

Auricular Acupressure (AA)

EXPERIMENTAL

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)

Self-Managed control group

PLACEBO COMPARATOR

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

Interventions

Auricular Acupressure (AA) BEHAVIORAL

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.

Auricular Acupressure (AA)

Transcutaneous Acupoints Electrical Stimulation (TAES) BEHAVIORAL

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.

Transcutaneous Acupoints Electrical Stimulation (TAES)

No intervention OTHER

No intervention

Self-Managed control group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: collaborator
• The Hong Kong Polytechnic University: lead

Study Sites (1)

Shanghai Children Medical Center

Shanghai, China

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ka Yan Ho, PhD

CONTACT

+85254844554; kyeva.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 12, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)