Clinical trial · Interventional
Transcutaneous Electrical Acupoint Stimulation on Symptoms Associated with Chemotherapy Induced Peripheral Neuropathy
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
NCT05904340CI-TRIAL-00082267recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test Group
- description
- 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.
- interventionNames
- Device: Transcutaneous Electrical Nerve Stimulation
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 4 weeks of usual care, including prescribe vitamin B6 or B12 and massage therapy. Assessing the severity of neuropathy symptoms every week.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (24)
- BACKGROUNDBurgess 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
- BACKGROUNDCalhoun 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
- BACKGROUNDCavaletti 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
- BACKGROUNDCavaletti 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.