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

NCT ID: NCT05904340

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-04-30

Brief Summary

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.

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).

Conditions

Breast Neoplasms; Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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.

Control Group

4 weeks of usual care, including prescribe vitamin B6 or B12 and massage therapy. Assessing the severity of neuropathy symptoms every week.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Transcutaneous Electrical Acupoint Stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Tsae Jyy, Wang

RN PhD Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

WANG, PHD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

Changhua Christian Hospital

Changhua, Changhua, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

CHIA HAO YANG

Role: CONTACT

henry1993110101@gmail.com

+886912631133

Facility Contacts

CHIA HAO YANG

Role: primary

henry1993110101@gmail.com

+886912631133

Hsiu Ying HSU, Master

Role: backup

14651@cch.org.tw

+886965066390

Hsiu Ying HSU, Master

Role: backup

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Other Identifiers

230302

Identifier Type: -

Identifier Source: org_study_id