PMID- 32493088 OWN - NLM STAT- MEDLINE DCOM- 20210818 LR - 20231111 IS - 1552-695X (Electronic) IS - 1534-7354 (Print) IS - 1534-7354 (Linking) VI - 19 DP - 2020 Jan-Dec TI - 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. PG - 1534735420925519 LID - 10.1177/1534735420925519 [doi] LID - 1534735420925519 AB - Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group (P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group (P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible. FAU - Song, Si-Yeon AU - Song SY AD - Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea. FAU - Park, Ji-Hye AU - Park JH AD - Seoul Korean Medicine Hospital of Daejeon University, Seoul, Republic of Korea. FAU - Lee, Jin Sun AU - Lee JS AD - Chungnam National University, Daejeon, Republic of Korea. FAU - Kim, Je Ryong AU - Kim JR AD - Chungnam National University, Daejeon, Republic of Korea. FAU - Sohn, Eun Hee AU - Sohn EH AD - Chungnam National University Hospital, Daejeon, Republic of Korea. FAU - Jung, Mi Sook AU - Jung MS AD - Chungnam National University, Daejeon, Republic of Korea. FAU - Yoo, Hwa-Seung AU - Yoo HS AUID- ORCID: 0000-0003-3738-3239 AD - Seoul Korean Medicine Hospital of Daejeon University, Seoul, Republic of Korea. LA - eng SI - CRiS/KCT0002357 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Integr Cancer Ther JT - Integrative cancer therapies JID - 101128834 RN - 0 (Antineoplastic Agents) SB - IM MH - *Antineoplastic Agents/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols MH - *Breast Neoplasms/drug therapy MH - *Electric Stimulation Therapy MH - Female MH - Humans MH - *Peripheral Nervous System Diseases/chemically induced/therapy MH - Quality of Life PMC - PMC7273579 OTO - NOTNLM OT - breast cancer OT - chemotherapy-induced peripheral neuropathy OT - health-related quality of life OT - low-frequency electrostimulation device COIS- Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2020/06/05 06:00 MHDA- 2021/08/19 06:00 PMCR- 2020/06/04 CRDT- 2020/06/05 06:00 PHST- 2020/06/05 06:00 [entrez] PHST- 2020/06/05 06:00 [pubmed] PHST- 2021/08/19 06:00 [medline] PHST- 2020/06/04 00:00 [pmc-release] AID - 10.1177_1534735420925519 [pii] AID - 10.1177/1534735420925519 [doi] PST - ppublish SO - Integr Cancer Ther. 2020 Jan-Dec;19:1534735420925519. doi: 10.1177/1534735420925519.