Improving Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: A Study of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure Interventions

Официальное название

Effectiveness of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure on Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: a Single Blind Randomized Controlled Study

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Auricular Acupressure (AA)
  Auricular 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.
• Другое No intervention
  No intervention

Первичные конечные точки

• CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN) [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]

Вторичные конечные точки (8)

• Sensory function outcomes [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Sensory function outcomes [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Motor and physical function [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Motor and physical function [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Motor and physical function [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Psychological distress [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Physical symptoms [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Quality of life outcome [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Children Medical Center — Шанхай

Идентификаторы

NCT: NCT07279818 · TAES and AA to treat CIPN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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