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

N/ANot Yet RecruitingNCT07279818

The Hong Kong Polytechnic University132 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)

To evaluate the severity of CIPN. The Pediatric Chemotherapy-Induced Neuropathy scale contains 13 items, with eight items to rate CIPN symptoms in the hands and feet and five items to rate the difficulty of performing functional tasks. The total score ranges from 0 to 65 with higher scores indicating more severe CIPN.