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

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

NCT ID: NCT05904340

Condition: Breast Neoplasms
Chemotherapy-induced Peripheral Neuropathy

Conditions: Official terms:
Breast Neoplasms
Peripheral Nervous System Diseases

Conditions: Keywords:
Breast Cancer
Chemotherapy-Induced Peripheral Neuropathy
Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Acupoint Stimulation

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Transcutaneous Electrical Nerve Stimulation
Description: 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.
Arm group label: Test Group

Other name: Transcutaneous Electrical Acupoint Stimulation

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).

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Changhua Christian Hospital

Address:
City: Changhua
Zip: 500
Country: Taiwan

Status: Recruiting

Contact:
Last name: CHIA HAO YANG

Phone: +886912631133
Email: henry1993110101@gmail.com

Contact backup:
Last name: Hsiu Ying HSU, Master

Phone: +886965066390
Email: 14651@cch.org.tw

Contact backup:
Last name: Hsiu Ying HSU, Master

Start date: July 1, 2023

Completion date: April 30, 2025

Lead sponsor:
Agency: National Taipei University of Nursing and Health Sciences
Agency class: Other

Collaborator:
Agency: Changhua Christian Hospital
Agency class: Other

Source: National Taipei University of Nursing and Health Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05904340