Breast NeoplasmsNCT05904340

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

A study testing Transcutaneous Electrical Nerve Stimulation in people with Breast Neoplasms and Chemotherapy-induced Peripheral Neuropathy, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Breast Neoplasms, Chemotherapy-induced Peripheral Neuropathy
What is being tested?: Transcutaneous Electrical Nerve Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteTaiwan
Study dates: 1 Jul 2023to 30 Apr 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

CHIA HAO YANG contact

+886912631133

henry1993110101@gmail.com

Taiwan1 site, 1 recruiting

Changhua Christian Hospital
Changhua, Changhua, 500
CHIA HAO YANG, +886912631133, henry1993110101@gmail.com
Hsiu Ying HSU, Master, +886965066390, 14651@cch.org.tw
Recruiting

Other trials in Taiwan

About this study

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

Read the 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
Being tested: Transcutaneous Electrical Nerve Stimulation
Keywords: Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy, Transcutaneous Electrical Nerve Stimulation, Transcutaneous Electrical Acupoint Stimulation
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Electrical Nerve StimulationDevice
Also called Transcutaneous Electrical Acupoint 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.

Study groups in NCT05904340
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: immediately after the intervention

Secondary outcomes (7)

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.
Measured: pre-intervention.
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.
Measured: up to 4 weeks.
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.
Measured: immediately after the intervention.
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.
Measured: pre-intervention.
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.
Measured: immediately after the intervention.
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.
Measured: pre-intervention.
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.
Measured: immediately after the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202330 Apr 2025

First posted15 Jun 2023
Study start1 Jul 2023
Primary completion30 Apr 2025 (estimated)
Study completion30 Apr 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 86 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05904340
Sponsor's protocol ID: 230302
Status last verified: Nov 2024
First submitted: 13 May 2023
Last updated: 6 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34655433
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.
PubMed 14675309
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.
PubMed 22910842
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.
PubMed 16787511
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.
PubMed 29873180
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.
PubMed 10584454
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.
PubMed 22588748
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.
PubMed 28449490
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.
PubMed 28839994
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.
PubMed 34073174
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.
PubMed 32676134
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.
PubMed 29321111
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.
PubMed 28286483
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
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.
PubMed 23017617

Interested in taking part?

CHIA HAO YANG

+886912631133

henry1993110101@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05904340
Acronym / sponsor ID: 230302
Conditions: Breast Neoplasms, Chemotherapy-induced Peripheral Neuropathy
Keywords: Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy, Transcutaneous Electrical Nerve Stimulation, Transcutaneous Electrical Acupoint Stimulation
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 86 participants (estimated)
Lead sponsor: National Taipei University of Nursing and Health SciencesUniversity, hospital or other
Collaborators: Changhua Christian Hospital
Study start: 1 Jul 2023 (actual)
Primary completion: 30 Apr 2025 (estimated)
Study completion: 30 Apr 2025 (estimated)
First posted: 15 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test Group	Experimental	Device: Transcutaneous Electrical Nerve StimulationThe 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.
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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcutaneous Electrical Nerve StimulationAlso: Transcutaneous Electrical Acupoint StimulationTranscutaneous 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.	Device	Test Group

Primary outcome

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
Time frame: pre-intervention.
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.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
Time frame: up to 4 weeks.
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.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX
Time frame: immediately after the intervention
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.

7 secondary outcomes

hand and foot pain Numerical Rating Scale
Time frame: pre-intervention.
hand and foot pain Numerical Rating Scale
Time frame: up to 4 weeks.
hand and foot pain Numerical Rating Scale
Time frame: immediately after the intervention.
Total Neuropathy Score clinical version
Time frame: pre-intervention.
Total Neuropathy Score clinical version
Time frame: immediately after the intervention.
Brief Pain Inventory interference items scores
Time frame: pre-intervention.
Brief Pain Inventory interference items scores
Time frame: immediately after the intervention.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
Background: PubMed 34655433Burgess 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.
Background: PubMed 14675309Calhoun 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.
Background: PubMed 22910842Cavaletti 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.
Background: PubMed 16787511Cavaletti 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.
Background: PubMed 29873180Cheng 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.
Background: PubMed 10584454Ger 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.
Background: PubMed 22588748Hawker 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.
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Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

CHIA HAO YANG contact

+886912631133

henry1993110101@gmail.com

WANG, PHD principal investigator

National Taipei University of Nursing and Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CHIA HAO YANG (+886912631133, henry1993110101@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity, FACT/GOG-NTX (time frame: pre-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05904340, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.