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

NCT ID: NCT07319481

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chemotherapy Induced Peripheral Neuropathy (CIPN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Transcutaneous Acupoints Electrical Stimulation (TAES)

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

No intervention: sham TAES

Intervention Type OTHER

It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.

Interventions

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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.

Intervention Type BEHAVIORAL

No intervention: sham TAES

It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

UNKNOWN

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Eva Ho

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital

Zhengzhou, , China

Site Status

Countries

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China

Central Contacts

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Ka Yan HO

Role: CONTACT

+85254844554

Facility Contacts

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Meng Meng Luo

Role: primary

0371-65588251

Other Identifiers

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Electrical stimulation

Identifier Type: -

Identifier Source: org_study_id

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