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

NCT07319481 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-06

No results posted yet for this study

Summary

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.

Conditions

  • Chemotherapy Induced Peripheral Neuropathy (CIPN)

Interventions

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.

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.

Sponsors & Collaborators

  • The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

    collaborator UNKNOWN

  • The Hong Kong Polytechnic University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319481 on ClinicalTrials.gov