Transcutaneous Electrical Acupoint Stimulation on Symptoms Associated with Chemotherapy Induced Peripheral Neuropathy

November 4, 2024 updated by: Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

The Efficacy of Social Media Assisted Home-based Transcutaneous Electrical Acupoint Stimulation on Symptoms Associated with Chemotherapy Induced Peripheral Neuropathy in Patients with Breast Cancer

Breast cancer ranks first in Taiwan's top ten gynecological cancers. Chemotherapy is a standard treatment method for colorectal cancer and breast cancer, but while destroying cancer cells, it also destroys healthy cells, resulting in side effects. Peripheral neuropathy can lead to peripheral nerve damage and decreased activity, which affects the patient's quality of life. Currently, there is no standard and effective method for treating peripheral neuropathy caused by chemotherapy. Therefore, the purpose of this study is to investigate the effect of percutaneous electrical acupoint stimulation on improving peripheral nerve symptoms in breast cancer patients undergoing chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer ranks first in Taiwan's top ten gynecological cancers. Chemotherapy is a standard treatment method for colorectal cancer and breast cancer, but while destroying cancer cells, it also destroys healthy cells, resulting in side effects. Peripheral neuropathy can lead to peripheral nerve damage and decreased activity, which affects the patient's quality of life. Currently, there is no standard and effective method for treating peripheral neuropathy caused by chemotherapy. Therefore, the purpose of this study is to investigate the effect of percutaneous electrical acupoint stimulation on improving peripheral nerve symptoms in breast cancer patients undergoing chemotherapy. An experimental study design will be adopted. A convenient sample of 86 patients with breast cancer who completed the chemotherapy course within one month will be recruited from outpatient clinics of a medical center in the middle district of Taiwan. Patients who are eligible and agree to participate will be randomly assigned to the transcutaneous electrical acupoint stimulation group or the control group. The transcutaneous electrical acupoint stimulation group will receive 4 weeks of transcutaneous electrical acupoint stimulation intervention, while the control group will not receive any measures related to this study. Data from both groups will be collected at the time of admission, the 1st week, the 2nd week, the 3rd week, and the 4th week. The study instruments include the cancer treatment-related quality of life neurotoxicity assessment subscale, Total Neuropathy Score clinical version, Brief Pain Inventory interference items scores and hand and foot pain Numerical Rating Scale. The obtained data will be statistically analyzed using SPSS software. The baseline equilibrium of the subjects' demographic and disease characteristics will be examined by the Chi-square test and independent sample T-test. For the main outcome variable Neurotoxicity Subscale and the Numerical Rating Scale for Hand and Foot Pain, generalized estimating equations were used to analyze the effects of between-group, time-to-group, and time-interaction effects. One-way analysis of variance (The Analysis of Variance, ANOVA) to examine intra- and inter-group differences between the clinical version of the Integrated Neuropathy Score and the Simple Pain Scale Interference Item score pretest and posttest (week 4).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
        • Contact:
        • Contact:
          • Hsiu Ying HSU, Master

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Primary diagnosed with breast cancer for the first time by a physician.
  2. Patients who have completed chemotherapy or postoperative adjuvant chemotherapy within 3 months, and the chemotherapy drugs used are paclitaxel, vinblastine or platinum drugs.
  3. Patients who have been evaluated by doctors as peripheral neuropathy caused by chemotherapy, and whose symptoms persist after completing chemotherapy.
  4. Peripheral sensory or peripheral motor neuropathy grade ≥ 2 in general toxicity criteria (NCI-CTCAE).
  5. Those who have clear consciousness and can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

  1. Patients suffering from carcinoma in situ.
  2. Patients suffering from stage IV cancer.
  3. Patients suffering from metastatic cancer.
  4. Patients receiving peripheral neuropathy drugs (Duloxetine)
  5. Patients receiving acupoint stimulation therapy.
  6. Patients who are allergic to silicone patches.
  7. Patients with cardiac pacemakers.
  8. Patients suffering from diabetic peripheral neuropathy.
  9. Patients suffering from peripheral neuropathy of acquired immunodeficiency syndrome.
  10. Patients receiving treatment for mental illness.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Group
The percutaneous nerve discharger (model GM350PP) of APEX low-frequency therapeutic device is used for transcutaneous electrical nerve stimulation of acupoints. The approved number of medical equipment license for this product is: Department of Health Medical Device No. 006696, and the use mode of intervention measures is P5 Disperse -Dense Modulation mode (discharge frequency 2Hz/wave width 260μs/duration 3sec and discharge frequency 100 Hz/wavewidth 140μs/continuation 3sec alternately, maximum discharge volume 80mA), stimulate Neiguan (PC6), Hegu (LI4), Sanyinjiao (SP6) and Taichong (LR3) points, twice a day, 30 minutes each time, for 4 weeks, the intensity is divided into 10-25 mA for hands and 25-40 mA for feet, depending on personal tolerance Adjust flexibly within the interval, and evaluate the severity of neuropathy symptoms of the test every week.
Device: Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Nerve Stimulation (TENS) uses machines to generate electric current, flows through the skin and conducts to the nerves, triggers a chain reaction of nerves through a new stimulus source, and achieves the effect of pain relief. Using different frequencies and intensities will Produce different effects and trigger different physiological mechanisms.
Other Names:
  • Transcutaneous Electrical Acupoint Stimulation
No Intervention: Control Group
4 weeks of usual care, including prescribe vitamin B6 or B12 and massage therapy. Assessing the severity of neuropathy symptoms every week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
Time Frame: pre-intervention.
sub-scale involve Sensory, motor, auditory and functional impairments, which can reflect the situation that the patient was troubled by symptoms in the past 7 days, a total of 11 items. Record answers in "item response" column. If missing, mark with an X. Perform reversals as indicated, and sum individual items to obtain a score. Multiply the sum of the item scores by the number of items in the subscale, then divide by the number of items answered.This produces the subscale score. The higher the score, the better the QOL.
pre-intervention.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
Time Frame: up to 4 weeks.
sub-scale involve Sensory, motor, auditory and functional impairments, which can reflect the situation that the patient was troubled by symptoms in the past 7 days, a total of 11 items. Record answers in "item response" column. If missing, mark with an X. Perform reversals as indicated, and sum individual items to obtain a score. Multiply the sum of the item scores by the number of items in the subscale, then divide by the number of items answered.This produces the subscale score. The higher the score, the better the QOL.
up to 4 weeks.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
Time Frame: immediately after the intervention
sub-scale involve Sensory, motor, auditory and functional impairments, which can reflect the situation that the patient was troubled by symptoms in the past 7 days, a total of 11 items. Record answers in "item response" column. If missing, mark with an X. Perform reversals as indicated, and sum individual items to obtain a score. Multiply the sum of the item scores by the number of items in the subscale, then divide by the number of items answered.This produces the subscale score. The higher the score, the better the QOL.
immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
hand and foot pain Numerical Rating Scale
Time Frame: pre-intervention.
Questions and answers on the severity of symptoms of neuropathic pain in the hands and feet, including burning pain, pins and needles, numbness, loss of sensation, evoked pain, such as touching cold objects, on a numerical scale from 0 to 10, where 0 indicates no symptoms and 1 -3 indicates mild symptoms, 4-6 indicates moderate symptoms, 7-10 indicates severe symptoms, and higher scores indicate more severe symptoms. Please fill in the most uncomfortable parts of your hands and feet, and circle or mark a number on each spectrum to express the answer that applies to you in the past 24 hours.
pre-intervention.
hand and foot pain Numerical Rating Scale
Time Frame: up to 4 weeks.
Questions and answers on the severity of symptoms of neuropathic pain in the hands and feet, including burning pain, pins and needles, numbness, loss of sensation, evoked pain, such as touching cold objects, on a numerical scale from 0 to 10, where 0 indicates no symptoms and 1 -3 indicates mild symptoms, 4-6 indicates moderate symptoms, 7-10 indicates severe symptoms, and higher scores indicate more severe symptoms. Please fill in the most uncomfortable parts of your hands and feet, and circle or mark a number on each spectrum to express the answer that applies to you in the past 24 hours.
up to 4 weeks.
hand and foot pain Numerical Rating Scale
Time Frame: immediately after the intervention.
Questions and answers on the severity of symptoms of neuropathic pain in the hands and feet, including burning pain, pins and needles, numbness, loss of sensation, evoked pain, such as touching cold objects, on a numerical scale from 0 to 10, where 0 indicates no symptoms and 1 -3 indicates mild symptoms, 4-6 indicates moderate symptoms, 7-10 indicates severe symptoms, and higher scores indicate more severe symptoms. Please fill in the most uncomfortable parts of your hands and feet, and circle or mark a number on each spectrum to express the answer that applies to you in the past 24 hours.
immediately after the intervention.
Total Neuropathy Score clinical version
Time Frame: pre-intervention.
The test consists of 7 items including motor, sensory, autonomic symptoms, and muscle strength. Each item is scored on a 5-point scale, with each item ranging from 0 to 4 points. The higher the score, the more severe the peripheral neuropathy.
pre-intervention.
Total Neuropathy Score clinical version
Time Frame: immediately after the intervention.
The test consists of 7 items including motor, sensory, autonomic symptoms, and muscle strength. Each item is scored on a 5-point scale, with each item ranging from 0 to 4 points. The higher the score, the more severe the peripheral neuropathy.
immediately after the intervention.
Brief Pain Inventory interference items scores
Time Frame: pre-intervention.
The extent to which pain affects general activity, mood, walking ability, work, relationship, sleep, and enjoyment of life There are 7 questions in total, and each question is scored with 11 points. Each question ranges from 0 (not affected) to 10 (completely affected). The higher the score, the more pain affects life. more serious interference.
pre-intervention.
Brief Pain Inventory interference items scores
Time Frame: immediately after the intervention.
The extent to which pain affects general activity, mood, walking ability, work, relationship, sleep, and enjoyment of life There are 7 questions in total, and each question is scored with 11 points. Each question ranges from 0 (not affected) to 10 (completely affected). The higher the score, the more pain affects life. more serious interference.
immediately after the intervention.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taipei University of Nursing and Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Changhua Christian Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: WANG, PHD, National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 230302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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