Clinical trial NCT05904340: Transcutaneous Electrical Acupoint Stimulation on Symptoms Associated with Chemotherapy Induced Peripheral Neuropathy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Chemotherapy-induced Peripheral Neuropathy
Keywords: Breast Cancer
Chemotherapy-Induced Peripheral Neuropathy
Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Acupoint Stimulation
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Changhua Christian Hospital
First posted: 2023-06-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
timeFrame: pre-intervention.
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
timeFrame: up to 4 weeks.
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
timeFrame: immediately after the intervention
Secondary outcomes:
measure: hand and foot pain Numerical Rating Scale
timeFrame: pre-intervention.
measure: hand and foot pain Numerical Rating Scale
timeFrame: up to 4 weeks.
measure: hand and foot pain Numerical Rating Scale
timeFrame: immediately after the intervention.
measure: Total Neuropathy Score clinical version
timeFrame: pre-intervention.
measure: Total Neuropathy Score clinical version
timeFrame: immediately after the intervention.
measure: Brief Pain Inventory interference items scores
timeFrame: pre-intervention.
measure: Brief Pain Inventory interference items scores
timeFrame: immediately after the intervention.
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: WANG, PHD
role: PRINCIPAL_INVESTIGATOR
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