About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Transcutaneous Acupoints Electrical Stimulation (TAES)
- Auricular Acupressure (AA)
- No intervention
Treatment groups
Sponsors and collaborators
The Hong Kong Polytechnic University
Lead sponsor
Shanghai Children's Medical Center
Collaborator