Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia
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.
No intervention: sham TAES: It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.
Study summary
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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria:
* 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)
* 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
* contraindications to TEAS : 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.
Primary outcome measure(s)
Feasibility measure - Screening rate — Baseline The number of participants being screened divided by the number of participants available for screening
Feasibility measure - Eligibility rate — Baseline The number of eligible participants divided by the number of screened participants.
Feasibility measure - Recruitment rate — Baseline The number of eligible participants who consent to join divided by the number of eligible participants
Feasibility measure - Randomization rate — Baseline The number of consented participants being randomized divided by the number of consented participants
Feasibility measure - Attendance rate — immediately after intervention (T1) The number of participants in the experimental group and control group who complete the intervention divided by the number of participants randomized into the group
Feasibility measure - Attrition rate — Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3) The number of participants who drop out divided by the number of participants randomized.
Feasilibility measure - Adverse events — During the study period including 8-week intervention and 3 months follow-up It will be denoted as the number of adverse events reported by the participants during the study period.
Trial sites (1)
Facility
City
Region
Status
The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
Zhengzhou
China
More The Hong Kong Polytechnic University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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