Effectiveness of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure on Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: a Single Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
研究概览
简要总结
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:
- 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?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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, liver or renal function
- •contraindications to TEAS or auricular acupressure: 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
CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
时间窗: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
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.
CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
时间窗: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
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.
次要结局
- Sensory function outcomes(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))
- Physical symptoms(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))
- Motor and physical function(Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3))
- Sensory function outcomes(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))
- Physical symptoms(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))
研究者
Dr Eva Ho
Associate professor
The Hong Kong Polytechnic University