Electro-Acupuncture Combined With Exercise for Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Taxanes or Platinum-based Agents: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Total Neuropathy Score-reduced (TNS-r)
研究概览
简要总结
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.
详细描述
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.
- Upper Extremity Acupoints: Quze (PC3), Neiguan (PC6), and Daling (PC7).
- Lower Extremity Acupoints: Zusanli (ST36), Sanyinjiao (SP6), Taixi (KI3), and Taichong (LR3).
- 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.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of electro-acupuncture and progressive balance training, blinding of the therapists (acupuncturists and physical therapists) and participants is not feasible. Therefore, this study adopts a single-blind (outcomes assessor-blinded) design. To maintain masking, outcomes assessors responsible for performing the neurological assessments and functional tests (including TNS-r, Mini-BESTest, and Semmes-Weinstein Monofilaments) are strictly separated from the therapists administering the interventions. These assessors perform all measurements in an independent, designated examination room and are prohibited from discussing group allocations with the participants. Furthermore, participants are explicitly instructed during education sessions not to disclose or discuss their specific treatment components with the assessors during any follow-up evaluations.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed cancer diagnosis with prior taxane or platinum-based chemotherapy.
- •CIPN symptoms staged as CTCAE Grade 1, 2, or
- •Life expectancy > 6 months and capable of independent ambulation.
排除标准
- •Presence of a cardiac pacemaker.
- •Severe coagulation disorders.
- •Neuropathy from other etiologies (non-chemotherapy induced).
研究组 & 干预措施
Electroacupuncture (EA) combined with progressive exercise training
Participants in this arm receive Electroacupuncture (EA) combined with a progressive multi-modal exercise training program. The intervention frequency is explicitly tailored according to the participant's attendance tier: Tier 1 attends once weekly, while Tier 2 attends twice weekly.
Each in-hospital session includes 20 minutes of EA followed by 30 minutes of progressive multi-modal exercise training. To ensure dosage consistency across both tiers, participants utilize a structured digital home-support platform via QR code videos to perform home-based exercises (Tier 1: twice weekly; Tier 2: once weekly), standardizing the total cumulative exercise volume to exactly 3 sessions per week for all participants.
干预措施: Electroacupuncture (Device)
Electroacupuncture (EA) combined with progressive exercise training
Participants in this arm receive Electroacupuncture (EA) combined with a progressive multi-modal exercise training program. The intervention frequency is explicitly tailored according to the participant's attendance tier: Tier 1 attends once weekly, while Tier 2 attends twice weekly.
Each in-hospital session includes 20 minutes of EA followed by 30 minutes of progressive multi-modal exercise training. To ensure dosage consistency across both tiers, participants utilize a structured digital home-support platform via QR code videos to perform home-based exercises (Tier 1: twice weekly; Tier 2: once weekly), standardizing the total cumulative exercise volume to exactly 3 sessions per week for all participants.
干预措施: Exercise Training (Behavioral)
Electroacupuncture (EA) combined with progressive exercise training
Participants in this arm receive Electroacupuncture (EA) combined with a progressive multi-modal exercise training program. The intervention frequency is explicitly tailored according to the participant's attendance tier: Tier 1 attends once weekly, while Tier 2 attends twice weekly.
Each in-hospital session includes 20 minutes of EA followed by 30 minutes of progressive multi-modal exercise training. To ensure dosage consistency across both tiers, participants utilize a structured digital home-support platform via QR code videos to perform home-based exercises (Tier 1: twice weekly; Tier 2: once weekly), standardizing the total cumulative exercise volume to exactly 3 sessions per week for all participants.
干预措施: Structured Home-Based Health Education and Dose-Controlled Exercise Program (Behavioral)
EA Only
Participants in this arm receive Electro-Acupuncture (EA) alone as an active control to match the acupuncture dosage of the experimental group. The in-hospital session frequency is identical to the experimental group and dictated by the stratification tier: Tier 1 attends once weekly, and Tier 2 attends twice weekly. Each session consists of 20 minutes of identical EA treatment at the same acupoints and stimulation parameters. No progressive balance training or home-based exercise videos are provided; instead, participants receive only general oral health, environment safety, and peripheral care education from the research team.
干预措施: Electroacupuncture (Device)
EA Only
Participants in this arm receive Electro-Acupuncture (EA) alone as an active control to match the acupuncture dosage of the experimental group. The in-hospital session frequency is identical to the experimental group and dictated by the stratification tier: Tier 1 attends once weekly, and Tier 2 attends twice weekly. Each session consists of 20 minutes of identical EA treatment at the same acupoints and stimulation parameters. No progressive balance training or home-based exercise videos are provided; instead, participants receive only general oral health, environment safety, and peripheral care education from the research team.
干预措施: General Health Education (Behavioral)
结局指标
主要结局
Total Neuropathy Score-reduced (TNS-r)
时间窗: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
The Total Neuropathy Score-reduced (TNS-r) is a validated clinical composite scale used in this study to quantitatively assess the severity of chemotherapy-induced peripheral neuropathy (CIPN). It integrates patient-reported symptoms with objective clinical signs, including ankle reflexes, pinprick and vibration thresholds, muscle strength, and nerve conduction. The assessment evaluates seven items, each graded on a scale from 0 (normal or no symptoms) to 4 (very severe). This grading provides a standardized measure where higher scores indicate more severe peripheral nerve impairment and neurological symptoms. In this trial, the TNS-r serves as the primary outcome measure to determine if the combined electro-acupuncture and exercise intervention effectively reduces neurological symptoms and promotes nerve repair over the 8-week study period.
Mini-Balance Evaluation Systems Test (Mini-BESTest)
时间窗: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a 14-item clinical instrument validated to quantitatively assess dynamic balance across four distinct contexts: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0 to 2, yielding a total score range of 0 to 28, where higher scores represent superior dynamic postural control, enhanced functional mobility, and a reduced risk of falls. In this trial, the Mini-BESTest serves as a co-primary outcome measure to evaluate the external functional rehabilitation efficacy of combining electroacupuncture with progressive multi-modal exercise training. It specifically detects improvements in dynamic postural stability, neuromuscular control, and proprioception over the 8-week intervention period.
Semmes-Weinstein Monofilaments
时间窗: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
Tactile sensation and sensory thresholds are objectively measured at specific anatomical sites on the bilateral upper and lower extremities using Semmes-Weinstein Monofilaments (SWM). Results will be analyzed based on the smallest filament size perceived by the participant. Lower filament values indicate finer tactile discrimination and improved sensory neurological function.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT/GOG-NTX)
时间窗: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
This questionnaire specifically measures the impact of chemotherapy-induced neurotoxicity on a participant's daily functional status. It comprises five subscales: Physical Well-Being (7 items, scored 0-4), Social/Family Well-Being (7 items, scored 0-4), Emotional Well-Being (6 items, scored 0-4), Functional Well-Being (7 items, scored 0-4), and an Additional Concerns/Neurotoxicity subscale (NTX subscale: 11 items assessing numbness, tingling, and dexterity, scored 0-4). Individual items are scored such that higher scores on well-being items and reverse-scored neurotoxicity items represent less symptom distress, reduced neurotoxic impact, and a higher level of daily functional well-being.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
This 30-item instrument evaluates the overall physical, psychological, and social functional status of cancer patients. Items 1-28 are scored on a 4-point scale (1: Not at all, to 4: Very much), and items 29-30 assess global health status and overall quality of life on a 7-point scale (1: Very poor, to 7: Excellent). All scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual. For functional scales and global quality of life, higher scores represent better functioning; for symptom scales (e.g., pain, fatigue, insomnia), higher scores indicate greater symptom severity and distress.
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
时间窗: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
This questionnaire measures the participant's subjective life satisfaction across four comprehensive domains: Physical Health, Psychological, Social Relationships, and Environment. It includes 26 core items scored on a 5-point Likert scale (1 to 5), plus 2 local items assessing respect and food availability (scored 1 to 5). Domain scores are calculated and transformed into a scale ranging from 4 to 20, aligned with the WHOQOL scoring guideline. Higher domain scores indicate a better subjective perception of quality of life and higher satisfaction.
次要结局
未报告次要终点
研究者
Lee I-Ting
doctor
Show Chwan Memorial Hospital