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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05904340
• Other study ID #: 230302
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: April 22, 2024

Study information

• Verified date: June 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: PHD
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: April 22, 2024
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 6 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (24)

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Hou L, Gu F, Gao G, Zhou C. Transcutaneous electrical acupoint stimulation (TEAS) ameliorates chemotherapy-induced bone marrow suppression in lung cancer patients. J Thorac Dis. 2017 Mar;9(3):809-817. doi: 10.21037/jtd.2017.03.12. — View Citation

Hou L, Zhou C, Wu Y, Yu Y, Hu Y. Transcutaneous electrical acupoint stimulation (TEAS) relieved cancer-related fatigue in non-small cell lung cancer (NSCLC) patients after chemotherapy. J Thorac Dis. 2017 Jul;9(7):1959-1966. doi: 10.21037/jtd.2017.06.05. — View Citation

Hung HW, Liu CY, Chen HF, Chang CC, Chen SC. Impact of Chemotherapy-Induced Peripheral Neuropathy on Quality of Life in Patients with Advanced Lung Cancer Receiving Platinum-Based Chemotherapy. Int J Environ Res Public Health. 2021 May 26;18(11):5677. doi: 10.3390/ijerph18115677. — View Citation

Iravani S, Kazemi Motlagh AH, Emami Razavi SZ, Shahi F, Wang J, Hou L, Sun W, Afshari Fard MR, Aghili M, Karimi M, Rezaeizadeh H, Zhao B. Effectiveness of Acupuncture Treatment on Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized, Assessor-Blinded, Controlled Trial. Pain Res Manag. 2020 Jun 29;2020:2504674. doi: 10.1155/2020/2504674. eCollection 2020. — View Citation

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Kerckhove N, Collin A, Conde S, Chaleteix C, Pezet D, Balayssac D. Long-Term Effects, Pathophysiological Mechanisms, and Risk Factors of Chemotherapy-Induced Peripheral Neuropathies: A Comprehensive Literature Review. Front Pharmacol. 2017 Feb 24;8:86. doi: 10.3389/fphar.2017.00086. eCollection 2017. — View Citation

Kim, S. Y., & Park, J. S. (2021). The Effect of Self-Acupressure on Peripheral Neuropathy, Disturbance in Daily Activity, and Quality of Life in Breast Cancer Patients undergoing Chemotherapy. Asian Oncology Nursing, 21, 129-139. http://www.dbpia.co.kr/journal/articleDetail?nodeId=NODE10606983

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Puskulluoglu M, Tomaszewski KA, Grela-Wojewoda A, Pacholczak-Madej R, Ebner F. Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Systematic Review. Medicina (Kaunas). 2022 Feb 14;58(2):284. doi: 10.3390/medicina58020284. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX	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.
Primary	Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX	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.
Primary	Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX	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	hand and foot pain Numerical Rating Scale	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.
Secondary	hand and foot pain Numerical Rating Scale	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.
Secondary	hand and foot pain Numerical Rating Scale	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.
Secondary	Total Neuropathy Score clinical version	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.
Secondary	Total Neuropathy Score clinical version	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.
Secondary	Brief Pain Inventory interference items scores	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.
Secondary	Brief Pain Inventory interference items scores	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.