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Not yet recruiting NCT07279818

Improving Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: A Study of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure Interventions

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), Auricular Acupressure (AA), No intervention.
Who it may be relevant to
Registry conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN). Basic parameters: 8 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 →

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Official title

Effectiveness of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure on Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: a Single Blind Randomized Controlled Study

Overview

The goal of this clinical trial is to compare the effectiveness of Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) on subject CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in Children with Leukemia. The main questions it aims to answer are: 1. Does TAES and AA can improve CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in children with Leukemia compared with self-management control group? 2. Does TAES yield improvements in CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes that are comparable to those achieved through AA in children with leukemia? This proposed research is designed to conduct a three-arm RCT comparing TAES, AA to usual care in children with leukemia. Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in AA group will receive 8 weeks on four acupoints. Subjects in self-management control group will receive usual care they will receive from the hospital. These three 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.
  • Behavioral Auricular Acupressure (AA)
    Auricular acupressure (AA) is a non-invasive therapy rooted in Traditional Chinese Medicine (TCM) that involves applying pressure to specific acupoints on the ear using Vaccaria seeds.
  • Other No intervention
    No intervention

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • Sensory function outcomes [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Sensory function outcomes [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Motor and physical function [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Motor and physical function [Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
  • Motor and physical function [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)]
  • Physical symptoms [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 8 and 17 years old
  • diagnosed with leukemia
  • 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, liver or renal function
  • contraindications to TEAS or auricular acupressure: 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
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Children Medical Center — Shanghai

Identifiers

NCT: NCT07279818 · TAES and AA to treat CIPN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗