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Not Yet RecruitingNCT07319481

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

Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Chinese Children With Acute Lymphoblastic Leukemia: A Randomized Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
The Hong Kong Polytechnic University · Academic / Other
Sex
All
Age
10 Years – 17 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALTranscutaneous 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.
OTHERNo intervention: sham TAESIt is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.

Timeline

Start date
2026-02-01
Primary completion
2027-01-31
Completion
2027-01-31
First posted
2026-01-06
Last updated
2026-01-06

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07319481. Inclusion in this directory is not an endorsement.