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.
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)
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.
No intervention: sham TAES
Other interventionIt is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.
Feasibility measure - Screening rate
The number of participants being screened divided by the number of participants available for screening
Feasibility measure - Eligibility rate
The number of eligible participants divided by the number of screened participants.
Feasibility measure - Recruitment rate
The number of eligible participants who consent to join divided by the number of eligible participants
Feasibility measure - Randomization rate
The number of consented participants being randomized divided by the number of consented participants
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.
Physical functioning - Timed Up and Go test
Timed Up and Go test (TUG) will be used to evaluate the physical function in children with ALL.
Physical functioning - 30-second sitting-rising test
30-second sitting-rising test will be used to evaluate the physical function in children with ALL.
Physical functioning - grip strength
Handheld grip strength meter will be used to evaluate the physical function in children with ALL.
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The Hong Kong Polytechnic University
Lead sponsor
Zhengzhou University
Collaborator
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