CancerEA-EX CIPNNCT07700901
Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A study testing Electroacupuncture, Exercise Training and General Health Education in people with Cancer and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Show Chwan Memorial Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Electroacupuncture, Exercise Training and General Health Education
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesTaiwan
- Study dates
- 23 Jul 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of a cardiac pacemaker.
- Severe coagulation disorders.
- Neuropathy from other etiologies (non-chemotherapy induced).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
ShowChwanMH
Changhua, Changhua, 500
I-TING LEE, +886988567227, iting.lee927@gmail.com
- Recruiting
Show Chwan Memorial Hospital
Changhua, 500009
I-TING LEE, +886988567227, iting.lee927@gmail.com
Show Chwan Integrative Medicine and Wellness Center, +886-47256166 ext66722 ext. +886970289894, bear20160126@gmail.com
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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:
- Multi-directional single-leg stepping tasks.
- Single-leg stance coupled with active trunk rotation control.
- Dynamic balance training integrated with synchronous upper extremity proprioceptive tasks and visual tracking.
- Progressive lunge ambulation combined with axial trunk rotations.
- Unilateral cross-knee touch balance-strength maneuvers.
- 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:
- Tier 1 : Completes 1 in-hospital session and 2 home-based sessions per week.
- 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.
- Being tested
- Electroacupuncture, Exercise Training, Structured Home-Based Health Education and Dose-Controlled Exercise Program, General Health Education
- Keywords
- Chemotherapy-induced peripheral neuropathy, Acupuncture, Exercise training
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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).
Exercise TrainingBehavioural
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.
Structured Home-Based Health Education and Dose-Controlled Exercise ProgramBehavioural
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.
General Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Electroacupuncture; Behavioral: General Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start23 Jul 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Show Chwan Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee I-Ting, Show Chwan Memorial Hospital
- Investigators
- I-Ting Lee, Principal investigator, Changhua Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700901
- Sponsor's protocol ID
- 1150407
- Other IDs
- 1150407
- Acronym
- EA-EX CIPN
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-Acupuncture Combined With Exercise for Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Taxanes or Platinum-based Agents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07700901
- Acronym / sponsor ID
- EA-EX CIPN / 1150407
- Keywords
- Chemotherapy-induced peripheral neuropathy, Acupuncture, Exercise training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Show Chwan Memorial HospitalUniversity, hospital or other
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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:
- Multi-directional single-leg stepping tasks.
- Single-leg stance coupled with active trunk rotation control.
- Dynamic balance training integrated with synchronous upper extremity proprioceptive tasks and visual tracking.
- Progressive lunge ambulation combined with axial trunk rotations.
- Unilateral cross-knee touch balance-strength maneuvers.
- 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:
- Tier 1 : Completes 1 in-hospital session and 2 home-based sessions per week.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) combined with progressive exercise training | Experimental | Device: Electroacupuncture, Behavioral: Exercise Training, Behavioral: Structured Home-Based Health Education and Dose-Controlled Exercise ProgramParticipants 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. |
| EA Only | Active comparator | Device: Electroacupuncture, Behavioral: General Health EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of a cardiac pacemaker.
- Severe coagulation disorders.
- Neuropathy from other etiologies (non-chemotherapy induced).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureA 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). | Device | EA Only, Electroacupuncture (EA) combined with progressive exercise training |
| Exercise TrainingA 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. | Behavioural | Electroacupuncture (EA) combined with progressive exercise training |
| Structured Home-Based Health Education and Dose-Controlled Exercise ProgramParticipants 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. | Behavioural | Electroacupuncture (EA) combined with progressive exercise training |
| General Health EducationParticipants 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. | Behavioural | EA Only |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
I-Ting Lee principal investigator
Changhua Show Chwan Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture, Exercise Training and General Health Education in people with Cancer and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Show Chwan Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact I-Ting Lee, Bachelor (+886-988567228, iting.lee927@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Neuropathy Score-reduced (TNS-r) (time frame: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.