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

NCT07700901 | Not Yet Recruiting

• 1 other identifier: 1150407
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

Chemotherapy-induced peripheral neuropathy; Acupuncture; Exercise training

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

• 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.

  Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

• 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.

  Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

• 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.

  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)

  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)

  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).

Study Arms (2)

Electroacupuncture (EA) combined with progressive exercise training

EXPERIMENTAL

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; Behavioral: Exercise Training; Behavioral: Structured Home-Based Health Education and Dose-Controlled Exercise Program

EA Only

ACTIVE COMPARATOR

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; Behavioral: General Health Education

Interventions

Electroacupuncture DEVICE

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).

EA Only; Electroacupuncture (EA) combined with progressive exercise training

Exercise Training BEHAVIORAL

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.

Electroacupuncture (EA) combined with progressive exercise training

Structured Home-Based Health Education and Dose-Controlled Exercise Program BEHAVIORAL

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.

Electroacupuncture (EA) combined with progressive exercise training

General Health Education BEHAVIORAL

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.

EA Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Show Chwan Memorial Hospital: lead

Study Sites (1)

ShowChwanMH

Changhua, Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Electroacupuncture; Exercise

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• I-Ting Lee

  Changhua Show Chwan Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Ting Lee, Bachelor

CONTACT

+886-988567228; iting.lee927@gmail.com

CHI-CHUAN, KAO

CONTACT

+886-970289894; bear20160126@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: This prospective, stratified randomized controlled trial (1:1 allocation) evaluates the synergistic efficacy of Electroacupuncture (EA) combined with progressive exercise training for chemotherapy-induced peripheral neuropathy (CIPN). Participants are stratified into two discrete tiers based on baseline CTCAE severity grades to minimize data deviation and optimize decision-making: Tier 1 (1 in-hospital) and Tier 2 (2 in-hospital). Within each tier, a third-party researcher uses a computer-generated sequence (block size of 4) to assign participants to the Experimental Group (EA + progressive exercise training) or Control Group (EA only). To ensure dosage consistency, weekly intervention frequency is tailored to the severity tier via a digital platform, standardizing the total cumulative exercise volume for both Tier 1 (1 in-hospital + 2 home sessions) and Tier 2 (2 in-hospital + 1 home session) to exactly 3 sessions per week.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

TW (1)