Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy (CIPN) (EA-EX CIPN)

July 7, 2026 updated by: Lee I-Ting, Show Chwan Memorial Hospital

Electro-Acupuncture Combined With Exercise for Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Taxanes or Platinum-based Agents: A Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed cancer diagnosis with prior taxane or platinum-based chemotherapy.
  2. CIPN symptoms staged as CTCAE Grade 1, 2, or 3.
  3. Life expectancy > 6 months and capable of independent ambulation.

Exclusion Criteria:

  1. Presence of a cardiac pacemaker.
  2. Severe coagulation disorders.
  3. Neuropathy from other etiologies (non-chemotherapy induced).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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).
Behavioral: 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.
Behavioral: 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 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.
Active Comparator: 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.
Device: 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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Neuropathy Score-reduced (TNS-r)
Time Frame: 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.
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: 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.
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
Semmes-Weinstein Monofilaments
Time Frame: 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.
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT/GOG-NTX)
Time Frame: 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.
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)
Time Frame: 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.
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: 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.
Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Show Chwan Memorial Hospital

Investigators

  • Principal Investigator: I-Ting Lee, Changhua Show Chwan Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1150407 (Other Identifier: The Institutional Review Board of Show Chwan Memorial Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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