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.
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)
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)
Parallel
Transcutaneous Acupoints Electrical Stimulation (TAES)
BehavioralTranscutaneous 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.
Auricular Acupressure (AA)
BehavioralAuricular 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.
No intervention
Other interventionNo intervention
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.
Sensory function outcomes
Touch sensation were measured using monofilament examination with the best of both 2 trials on each side averaged.
Sensory function outcomes
Vibration sensation were measured using a 128 Hz tuning fork, with the best of both 2 trials on each side averaged.
Motor and physical function
Timed Up and Go test (TUG) will be used to evaluate the motor and physical function in children with leukemia.
Motor and physical function
30-second sitting-rising test will be used to evaluate the motor and physical function in children with leukemia.
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The Hong Kong Polytechnic University
Lead sponsor
Shanghai Children's Medical Center
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
