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

NCT05904340 | Recruiting

• 1 other identifier: 230302
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Chemotherapy-induced Peripheral Neuropathy

Keywords

Breast Cancer; Chemotherapy-Induced Peripheral Neuropathy; Transcutaneous Electrical Nerve Stimulation; Transcutaneous Electrical Acupoint Stimulation

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (7)

• hand and foot pain Numerical Rating Scale

  pre-intervention.

• hand and foot pain Numerical Rating Scale

  up to 4 weeks.

• hand and foot pain Numerical Rating Scale

  immediately after the intervention.

• Total Neuropathy Score clinical version

  pre-intervention.

• Total Neuropathy Score clinical version

  immediately after the intervention.

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Transcutaneous Electrical Nerve Stimulation 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.

Also known as: Transcutaneous Electrical Acupoint Stimulation

Test Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosed with breast cancer for the first time by a physician.
• Patients who have completed chemotherapy or postoperative adjuvant chemotherapy within 3 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Changhua Christian Hospital: collaborator

Study Sites (1)

Changhua Christian Hospital

Changhua, Changhua, 500, Taiwan

RECRUITING

Related Publications (24)

• Burgess J, Ferdousi M, Gosal D, Boon C, Matsumoto K, Marshall A, Mak T, Marshall A, Frank B, Malik RA, Alam U. Chemotherapy-Induced Peripheral Neuropathy: Epidemiology, Pathomechanisms and Treatment. Oncol Ther. 2021 Dec;9(2):385-450. doi: 10.1007/s40487-021-00168-y. Epub 2021 Oct 16.

  PMID: 34655433 BACKGROUND

• Calhoun EA, Welshman EE, Chang CH, Lurain JR, Fishman DA, Hunt TL, Cella D. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer. 2003 Nov-Dec;13(6):741-8. doi: 10.1111/j.1525-1438.2003.13603.x.

  PMID: 14675309 BACKGROUND

• Cavaletti G, Cornblath DR, Merkies ISJ, Postma TJ, Rossi E, Frigeni B, Alberti P, Bruna J, Velasco R, Argyriou AA, Kalofonos HP, Psimaras D, Ricard D, Pace A, Galie E, Briani C, Dalla Torre C, Faber CG, Lalisang RI, Boogerd W, Brandsma D, Koeppen S, Hense J, Storey D, Kerrigan S, Schenone A, Fabbri S, Valsecchi MG; CI-PeriNomS Group; Mazzeo A, Pace A, Pessino A, Schenone A, Toscano A, Argyriou AA, Brouwer B, Frigeni B, Piras B, Briani C, Dalla Torre C, Dominguez Gonzalez C, Faber CG, Tomasello C, Binda D, Brandsma D, Cortinovis D, Psimaras D, Ricard D, Storey D, Cornblath DR, Galie E, Lindeck Pozza E, Rossi E, Vanhoutte EK, Lanzani F, Pastorelli F, Altavilla G, Cavaletti G, Granata G, Kalofonos HP, Ghignotti I, Merkies ISJ, Bruna J, Hense J, Heimans JJ, Mattavelli L, Padua L, Reni L, Bakkers M, Boogerd M, Campagnolo M, Cazzaniga M, Eurelings M, Leandri M, Lucchetta M, Penas Prado M, Russo M, Valsecchi MG, Piatti ML, Alberti P, Bidoli P, Grant R, Plasmati R, Velasco R, Lalisang RI, Meijer RJ, Fabbri S, Dorsey SG, Galimberti S, Kerrigan S, Koeppen S, Postma TJ, Boogerd W, Grisold W. The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings. Ann Oncol. 2013 Feb;24(2):454-462. doi: 10.1093/annonc/mds329. Epub 2012 Aug 21.

  PMID: 22910842 BACKGROUND

• Cavaletti G, Jann S, Pace A, Plasmati R, Siciliano G, Briani C, Cocito D, Padua L, Ghiglione E, Manicone M, Giussani G; Italian NETox Group. Multi-center assessment of the Total Neuropathy Score for chemotherapy-induced peripheral neurotoxicity. J Peripher Nerv Syst. 2006 Jun;11(2):135-41. doi: 10.1111/j.1085-9489.2006.00078.x.

  PMID: 16787511 BACKGROUND

• Cheng HL, Molassiotis A. Longitudinal validation and comparison of the Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20) and the Functional Assessment of Cancer-Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx). Asia Pac J Clin Oncol. 2019 Feb;15(1):56-62. doi: 10.1111/ajco.13000. Epub 2018 Jun 5.

  PMID: 29873180 BACKGROUND

• Ger LP, Ho ST, Sun WZ, Wang MS, Cleeland CS. Validation of the Brief Pain Inventory in a Taiwanese population. J Pain Symptom Manage. 1999 Nov;18(5):316-22. doi: 10.1016/s0885-3924(99)00087-1.

  PMID: 10584454 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• 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.

  PMID: 28449490 BACKGROUND

• 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.

  PMID: 28839994 BACKGROUND

• 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.

  PMID: 34073174 BACKGROUND

• 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.

  PMID: 32676134 BACKGROUND

• Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.

  PMID: 29321111 BACKGROUND

• 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.

  PMID: 28286483 BACKGROUND

• 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

  BACKGROUND

• Oldenmenger WH, de Raaf PJ, de Klerk C, van der Rijt CC. Cut points on 0-10 numeric rating scales for symptoms included in the Edmonton Symptom Assessment Scale in cancer patients: a systematic review. J Pain Symptom Manage. 2013 Jun;45(6):1083-93. doi: 10.1016/j.jpainsymman.2012.06.007. Epub 2012 Sep 25.

  PMID: 23017617 BACKGROUND

• 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.

  PMID: 35208610 BACKGROUND

• Rossoff, J., & Mithal, L. B. (2018). Initial Management of Fever and Neutropenia: A Practical Approach. Clinical Pediatric Emergency Medicine, 19(2), 145-152.

  BACKGROUND

• Salat K. Chemotherapy-induced peripheral neuropathy-part 2: focus on the prevention of oxaliplatin-induced neurotoxicity. Pharmacol Rep. 2020 Jun;72(3):508-527. doi: 10.1007/s43440-020-00106-1. Epub 2020 Apr 28.

  PMID: 32347537 BACKGROUND

• Siregar, E., Herawati, L., Runjati, & Erisna, M. (2020). The Effect ofAcupressure and Acupunture as Natural Induction Methods for Spontaneous Labor: A Systematic Review. International Journal of Nursing and Health Services, 3(6), 743-753. https://doi.org/http://doi.org.10.35654/ijnhs.v3i6.361

  BACKGROUND

• Song SY, Park JH, Lee JS, Kim JR, Sohn EH, Jung MS, Yoo HS. A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420925519. doi: 10.1177/1534735420925519.

  PMID: 32493088 BACKGROUND

• Tsai CH, Lin YH, Li YS, Ho TL, Hoai Thuong LH, Liu YH. Integrated Medicine for Chemotherapy-Induced Peripheral Neuropathy. Int J Mol Sci. 2021 Aug 26;22(17):9257. doi: 10.3390/ijms22179257.

  PMID: 34502166 BACKGROUND

• Wong R, Major P, Sagar S. Phase 2 Study of Acupuncture-Like Transcutaneous Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy. Integr Cancer Ther. 2016 Jun;15(2):153-64. doi: 10.1177/1534735415627926. Epub 2016 Apr 29.

  PMID: 27130723 BACKGROUND

• Xie J, Chen LH, Ning ZY, Zhang CY, Chen H, Chen Z, Meng ZQ, Zhu XY. Effect of transcutaneous electrical acupoint stimulation combined with palonosetron on chemotherapy-induced nausea and vomiting: a single-blind, randomized, controlled trial. Chin J Cancer. 2017 Jan 10;36(1):6. doi: 10.1186/s40880-016-0176-1.

  PMID: 28069044 BACKGROUND

• Zajaczkowska R, Kocot-Kepska M, Leppert W, Wrzosek A, Mika J, Wordliczek J. Mechanisms of Chemotherapy-Induced Peripheral Neuropathy. Int J Mol Sci. 2019 Mar 22;20(6):1451. doi: 10.3390/ijms20061451.

  PMID: 30909387 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• WANG, PHD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHIA HAO YANG

CONTACT

+886912631133; henry1993110101@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD Professor

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)