Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia

Официальное название

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

Обзор

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.

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.
• Другое No intervention: sham TAES
  It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.

Первичные конечные точки

• Feasibility measure - Screening rate [Срок оценки: Baseline]
• Feasibility measure - Eligibility rate [Срок оценки: Baseline]
• Feasibility measure - Recruitment rate [Срок оценки: Baseline]
• Feasibility measure - Randomization rate [Срок оценки: Baseline]
• Feasibility measure - Attendance rate [Срок оценки: immediately after intervention (T1)]
• Feasibility measure - Attrition rate [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Feasilibility measure - Adverse events [Срок оценки: During the study period including 8-week intervention and 3 months follow-up]

Вторичные конечные точки (6)

• 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)]
• Physical functioning - Timed Up and Go test [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Physical functioning - 30-second sitting-rising test [Срок оценки: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)]
• Physical functioning - grip strength [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)]
• 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 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

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
• 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.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital — Чжэнчжоу

Идентификаторы

NCT: NCT07319481 · Electrical stimulation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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