Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShow Chwan Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of a cardiac pacemaker.
Severe coagulation disorders.
Neuropathy from other etiologies (non-chemotherapy induced).
Trial design
Design model
Parallel
Treatments tested in this trial
Electroacupuncture
DeviceA 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).
Exercise Training
BehavioralA 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.
Structured Home-Based Health Education and Dose-Controlled Exercise Program
BehavioralParticipants 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 identical total weekly intervention dose across the group, the frequency is tailored based on stratification: Tier 1 (1 in-hospital session) will practice 2 times/week at home; Tier 2 (2 in-hospital sessions) will practice 1 time/week at home. This ensures a total exercise volume of 3 sessions per week for all participants in this group. Home Exercise Log: Participants are required to maintain a daily log to track practice frequency and recording subjective feedback.
General Health Education
BehavioralParticipants 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.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Electroacupuncture (EA) combined with progressive exercise trainingExperimental treatment 3 interventions
Group B: EA OnlyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Total Neuropathy Score-reduced (TNS-r)
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.
Time frame
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).2
Mini-Balance Evaluation Systems Test (Mini-BESTest)
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.
Time frame
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).3
Semmes-Weinstein Monofilaments
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.
Time frame
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).4
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT/GOG-NTX)
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.
Time frame
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).Sponsors and contacts
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Source ClinicalTrials.gov