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
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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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2026-02-01
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
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.
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 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.
No intervention: sham TAES
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.
No intervention: sham TAES
It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
17 Years
ALL
No
Sponsors
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The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
UNKNOWN
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Dr Eva Ho
Associate professor
Locations
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The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Electrical stimulation
Identifier Type: -
Identifier Source: org_study_id
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