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

Sponsor

National Taipei University of Nursing and Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05904340

Collaborator

Changhua Christian Hospital (Other)

Enrollment

Location

Arms

9.7

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Chemotherapy-induced Peripheral Neuropathy	Device: Transcutaneous Electrical Nerve Stimulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 22, 2023

Anticipated Study Completion Date :

Apr 22, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX [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.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX [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.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX [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.

Secondary Outcome Measures

hand and foot pain Numerical Rating Scale [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.
hand and foot pain Numerical Rating Scale [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.
hand and foot pain Numerical Rating Scale [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.
Total Neuropathy Score clinical version [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.
Total Neuropathy Score clinical version [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.
Brief Pain Inventory interference items scores [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.
Brief Pain Inventory interference items scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary diagnosed with breast cancer for the first time by a physician.
Patients who have completed chemotherapy or postoperative adjuvant chemotherapy within 6 months, and the chemotherapy drugs used are paclitaxel, vinblastine or platinum drugs.
Patients who have been evaluated by doctors as peripheral neuropathy caused by chemotherapy, and whose symptoms persist after completing chemotherapy.
Peripheral sensory or peripheral motor neuropathy grade ≥ 2 in general toxicity criteria (NCI-CTCAE).
Those who have clear consciousness and can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

Patients suffering from carcinoma in situ.
Patients suffering from stage IV cancer.
Patients suffering from metastatic cancer.
Patients receiving peripheral neuropathy drugs (Duloxetine)
Patients receiving acupoint stimulation therapy.
Patients who are allergic to silicone patches.
Patients with cardiac pacemakers.
Patients suffering from diabetic peripheral neuropathy.
Patients suffering from peripheral neuropathy of acquired immunodeficiency syndrome.
Patients receiving treatment for mental illness.