Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Electroacupuncture, Exercise Training, Structured Home-Based Health Education and Dose-Controlled Exercise Program, General Health Education.
- Кому может быть актуально
- Состояния в реестре: Cancer, Chemotherapy-induced Peripheral Neuropathy (CIPN). Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Electro-Acupuncture Combined With Exercise for Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Taxanes or Platinum-based Agents: A Randomized Controlled Trial
Обзор
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment that causes numbness, pain, and balance issues in a patient's hands and feet. This study focuses on finding a non-drug approach to help cancer survivors manage these uncomfortable symptoms. The main purpose of this research is to evaluate whether combining Electroacupuncture(EA) with a exercise training program works better than using electroacupuncture alone. Electroacupuncture uses gentle electrical pulses through acupuncture needles to stimulate nerves, while the exercise program aims to improve a patient's balance, physical strength, and movement safety. Participants will be randomly assigned to receive either the combination therapy or electroacupuncture alone. The study involves scheduled hospital visits along with home-based practice guided by instructional videos. The researchers aim to evaluate the efficacy of combined EA and exercise training program on neurological symptoms and quality of life in CIPN patients across different CTCAE grades.
Подробное описание
I. Rationale and Synergistic Mechanisms Chemotherapy-induced peripheral neuropathy (CIPN) represents a highly prevalent and debilitating neurotoxic syndrome in cancer survivors treated with taxanes or platinum-based agents. Clinically, it presents as persistent symmetrical paresthesia, burning sensations, neuropathic pain, and significant proprioceptive deficits in the extremities. While conventional pharmacological management frequently yields suboptimal efficacy or introduces intolerable central nervous system adverse effects, this protocol investigates a non-pharmacological, integrative medical strategy combining Electro-Acupuncture (EA) with progressive multi-modal exercise training.
The scientific rationale predicates on a dual-pathway synergistic mechanism: EA serves as an internal neuro-modulatory intervention that delivers stable micro-currents to deep acupoints, thereby stimulating the endogenous opioid system, down-regulating systemic and local pro-inflammatory cytokines, optimizing microcirculation, and facilitating axonal myelin sheath regeneration. Concurrently, the progressive exercise training serves as an external functional rehabilitation mechanism. By driving neuromuscular retraining, exercise reinforces cortical-peripheral functional connectivity and enhances dynamic postural control, thereby counteracting the structural proprioceptive deficits unaddressed by acupuncture alone.
II. Technical Standardization of Interventions The therapeutic protocol is rigorously standardized over an 8-week duration, leveraging an integrated in-hospital and digital home-based framework to guarantee a uniform total dosage of three intervention sessions per week for all participants.
A. Electroacupuncture (EA) Protocol: Acupuncture is delivered by certified clinical practitioners targeting predefined bilateral acupoints to elicit the characteristic "de-qi" sensation (soreness, numbness, distension). Stimulus is applied via an electrical stimulator configured to a dense-disperse wave frequency of 2/100 Hz for a fixed duration of 20 minutes.
1. Upper Extremity Acupoints: Quze (PC3), Neiguan (PC6), and Daling (PC7). 2. Lower Extremity Acupoints: Zusanli (ST36), Sanyinjiao (SP6), Taixi (KI3), and Taichong (LR3). 3. Frequency Allocation: The protocol's frequency is determined by the in-hospital attendance cohorts. Participants under Tier 1 are allocated to receive 1 in-hospital session/week, whereas participants under Tier 2 are allocated to receive 2 in-hospital sessions/week.
B. Progressive Multi-Modal Exercise Training (Experimental Group Only): Immediately following the termination of EA, participants engage in 30 minutes of supervised, progressive balance and neuromuscular exercises. The exercise intensity is strictly regulated within a moderate range, corresponding to a Rating of Perceived Exertion (RPE) of 11 to 14. The dynamic regimen incorporates:
1. Multi-directional single-leg stepping tasks. 2. Single-leg stance coupled with active trunk rotation control. 3. Dynamic balance training integrated with synchronous upper extremity proprioceptive tasks and visual tracking. 4. Progressive lunge ambulation combined with axial trunk rotations. 5. Unilateral cross-knee touch balance-strength maneuvers.
C. Digital Home Support and Dosage Synchronization: To equalize the cumulative therapeutic volume across different baseline severity cohorts, a structured home support system is deployed via a dedicated intelligent digital platform:
1. Tier 1 : Completes 1 in-hospital session and 2 home-based sessions per week. 2. Tier 2 : Completes 2 in-hospital sessions and 1 home-based session per week. Home compliance is enforced via customized QR codes linking to institutional instructional videos for standardized exercise execution and complementary acupressure. Participants maintain a structured electronic "Home Exercise Diary" to log adherence, task completion frequencies, and subjective post-exercise fatigue.
III. Statistical Analysis Considerations To accommodate clinical attrition common among oncology patient populations undergoing post-chemotherapy surveillance, the total sample size incorporates an anticipated 15% drop-out rate to secure evaluable final data datasets. The longitudinal therapeutic effects across multiple discrete intervals (Baseline, Week 4, and Week 8) will be primarily evaluated using Repeated Measures Analysis of Variance (RM-ANOVA) to isolate inter-group and intra-group variances. Subgroup analyses will be systematically executed based on baseline symptom stratifications to detect severity-specific treatment responses, with Pearson's correlation coefficients utilized to ascertain the specific mathematical relationship between home exercise compliance and functional balance increments.
Вмешательства
- Устройство Electroacupuncture
A standardized electroacupuncture stimulation administered to specific upper limb acupoints (PC6, LI11, HT7) and lower limb acupoints (ST36, SP6, KI3, LR3) for 20 minutes per session. A dense-disperse wave profile at a frequency of 2/100 Hz is applied, with the intensity adjusted to the participant's maximum comfortable level without inducing pain ("De-Qi" sensation). - Поведенческое Exercise Training
A 30-minute structured, progressive exercise regimen focusing on balance, muscle strength, sensory integration, and coordination. The program features moderate-intensity activities (RPE 11-14) including multi-directional stepping, trunk rotation control, dynamic balance integrated with upper limb proprioception/visual tracking, progressive squat-walking, and cross-knee touch balance training. - Поведенческое Structured Home-Based Health Education and Dose-Controlled Exercise Program
Participants in the experimental group will receive a structured home support and health education program designed to enhance the therapeutic effects of the in-hospital intervention. The intervention includes: Daily Safety and Protection Guidance: Education on environmental safety and peripheral neuropathy protection . Dose-Controlled Home Exercise \& Acupressure: Participants will practice home-based exercises and acupressure guided by instructional videos via QR codes. To maintain an identi - Поведенческое General Health Education
Participants in the control group will receive routine, standard-of-care health education delivered by clinical staff during their hospital visits. This educational session covers general, non-structured advice on daily care and safety precautions for patients undergoing chemotherapy.
Первичные конечные точки
- Total Neuropathy Score-reduced (TNS-r) [Срок оценки: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).]
- Mini-Balance Evaluation Systems Test (Mini-BESTest) [Срок оценки: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).]
- Semmes-Weinstein Monofilaments [Срок оценки: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).]
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT/GOG-NTX) [Срок оценки: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).]
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Срок оценки: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).]
- World Health Organization Quality of Life-BREF (WHOQOL-BREF) [Срок оценки: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).]
Критерии участия
Критерии включения
- Confirmed cancer diagnosis with prior taxane or platinum-based chemotherapy.
- CIPN symptoms staged as CTCAE Grade 1, 2, or 3.
- Life expectancy > 6 months and capable of independent ambulation.
Критерии исключения
- Presence of a cardiac pacemaker.
- Severe coagulation disorders.
- Neuropathy from other etiologies (non-chemotherapy induced).
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
- Лечение
Центры проведения
Тайвань · 1 центр
- ShowChwanMH — Changhua
Идентификаторы
NCT: NCT07700901 · 1150407 · 1150407