Menu
Not yet recruiting NCT07319481

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

No phase Interventional Chemotherapy Induced Peripheral Neuropathy (CIPN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Acupoints Electrical Stimulation (TAES), No intervention: sham TAES.
Who it may be relevant to
Registry conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN). Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Feasibility measure - Screening rate [Time frame: Baseline]
  • Feasibility measure - Eligibility rate [Time frame: Baseline]
  • Feasibility measure - Recruitment rate [Time frame: Baseline]
  • Feasibility measure - Randomization rate [Time frame: Baseline]
  • Feasibility measure - Attendance rate [Time frame: immediately after intervention (T1)]
  • Feasibility measure - Attrition rate [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Feasilibility measure - Adverse events [Time frame: During the study period including 8-week intervention and 3 months follow-up]
Secondary outcome measures (6)
  • CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN) [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Physical functioning - Timed Up and Go test [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Physical functioning - 30-second sitting-rising test [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Physical functioning - grip strength [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Psychological distress [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Quality of life outcome [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital — Zhengzhou

Identifiers

NCT: NCT07319481 · Electrical stimulation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗