Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Chinese Children With Acute Lymphoblastic Leukemia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility measure - Screening rate
研究概览
简要总结
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:
- What is the feasibility of implementing TAES for children with ALL, as measured by the eligibility rate, consent rate, randomization rate etc.?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Feasibility measure - Screening rate
时间窗: Baseline
The number of participants being screened divided by the number of participants available for screening
Feasibility measure - Recruitment rate
时间窗: Baseline
The number of eligible participants who consent to join divided by the number of eligible participants
Feasibility measure - Attendance rate
时间窗: 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 - Eligibility rate
时间窗: Baseline
The number of eligible participants divided by the number of screened participants.
Feasibility measure - Attrition rate
时间窗: 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
时间窗: 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.
Feasibility measure - Randomization rate
时间窗: Baseline
The number of consented participants being randomized divided by the number of consented participants
次要结局
- Physical functioning - 30-second sitting-rising test(Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3))
- Quality of life outcome(Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3))
- CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)(Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3))
- Physical functioning - grip strength(Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3))
- Physical functioning - Timed Up and Go test(Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3))
- Psychological distress(Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3))
研究者
Dr Eva Ho
Associate professor
The Hong Kong Polytechnic University