PMID- 35952460 OWN - NLM STAT- MEDLINE DCOM- 20221018 LR - 20221028 IS - 1532-2122 (Electronic) IS - 1462-3889 (Print) IS - 1462-3889 (Linking) VI - 60 DP - 2022 Oct TI - A randomised, pragmatic clinical trial of ACUpuncture plus standard care versus standard care alone FOr Chemotherapy Induced peripheral Neuropathy (ACUFOCIN). PG - 102171 LID - S1462-3889(22)00079-5 [pii] LID - 10.1016/j.ejon.2022.102171 [doi] LID - 102171 AB - PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose limiting toxicity posing a major clinical challenge for managing patients receiving specific chemotherapy regimens (e.g., Taxanes). There is a growing body of literature suggesting acupuncture can improve CIPN symptoms. The purpose of the ACUFOCIN trial was to collect preliminary data on the safety, feasibility, acceptability and initial effectiveness of acupuncture as a treatment for CIPN, comparing use of acupuncture plus standard care (Acupuncture) against standard care alone (Control). METHOD: At a tertiary cancer centre, a pragmatic, randomised, parallel group design study was used to investigate the effectiveness of a 10-week course of acupuncture. Participants experiencing CIPN of >/= Grade II, recording a 'Most Troublesome' CIPN symptom score of >/=3 using the "Measure Yourself Medical Outcome Profile" (MYMOP 2), were randomised to 'Acupuncture' or 'Control' arms. Clinicians were blinded to allocated groups, however as it was not possible to blind participants, it cannot be guaranteed they did not disclose study allocation within their clinic assessments. The primary outcome measure was the number of patients reporting a >/= 2-point improvement (success) in their MYMOP2 score at week 10. 100 participants (120 to allow for attrition) were required for a hypothesised improvement in success proportions from 30% to 55% using a primary analysis model with logistic regression adjusted for stratification factors and baseline MYMOP2 scores. Feasibility and acceptability of study design was addressed through percentage return of primary outcome, retention rate and a nested qualitative study. RESULTS: Primary MYMOP2 outcome data at week 10 was available for 108/120 randomised participants; this is greater than the 100 participants required to adequately power the study. There were 36/53 (68%) successes in 'Acupuncture' compared to 18/55 (33%) in 'Control'. Beneficial effects were seen in the secondary outcome data, including clinicians' grading of neuropathy, EORTC, QLQ-CIPN20, QLQ-C30 summary scores and patient reported pain scores. There were no serious adverse events reported within the study and only 16 acupuncture associated events, none of which required intervention. CONCLUSION: A 10-week course of acupuncture resulted in measurable improvement in participants symptoms of CIPN. The results warrant further investigation. CI - Copyright (c) 2022 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Stringer, Jacqui AU - Stringer J AD - The Christie NHS Foundation Trust, Wilmslow Rd, Manchester, M20 4BX, UK; School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK. Electronic address: jacqui.stringer3@nhs.net. FAU - Ryder, W David AU - Ryder WD AD - Manchester Clinical Trials Unit, Faculty of Biology, Medicine and Health, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK. Electronic address: david.ryder@manchester.ac.uk. FAU - Mackereth, Peter A AU - Mackereth PA AD - The Christie NHS Foundation Trust, Wilmslow Rd, Manchester, M20 4BX, UK. Electronic address: petermackereth@icloud.com. FAU - Misra, Vivek AU - Misra V AD - The Christie NHS Foundation Trust, Wilmslow Rd, Manchester, M20 4BX, UK. Electronic address: vivek.misra@nhs.net. FAU - Wardley, Andrew M AU - Wardley AM AD - School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK; Outreach Research & Innovation Group, Adamson House, Ground Floor, Towers Business Park, Wilmslow Road, Didsbury, M20 2YY, UK. Electronic address: Andrew.Wardley@Outreach-Research-Innovation.com. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20220711 PL - Scotland TA - Eur J Oncol Nurs JT - European journal of oncology nursing : the official journal of European Oncology Nursing Society JID - 100885136 RN - 0 (Antineoplastic Agents) RN - 0 (Taxoids) SB - IM MH - *Acupuncture Therapy/adverse effects/methods MH - *Antineoplastic Agents/adverse effects MH - Humans MH - *Peripheral Nervous System Diseases/chemically induced/diagnosis/therapy MH - Quality of Life MH - Research Design MH - Taxoids/adverse effects PMC - PMC9592667 OTO - NOTNLM OT - Acupuncture OT - Chemotherapy induced peripheral neuropathy OT - Controlled trial COIS- Declaration of competing interest The authors declare that they have no competing interests. EDAT- 2022/08/12 06:00 MHDA- 2022/10/19 06:00 PMCR- 2022/10/01 CRDT- 2022/08/11 18:20 PHST- 2021/12/13 00:00 [received] PHST- 2022/06/21 00:00 [revised] PHST- 2022/07/03 00:00 [accepted] PHST- 2022/08/12 06:00 [pubmed] PHST- 2022/10/19 06:00 [medline] PHST- 2022/08/11 18:20 [entrez] PHST- 2022/10/01 00:00 [pmc-release] AID - S1462-3889(22)00079-5 [pii] AID - 102171 [pii] AID - 10.1016/j.ejon.2022.102171 [doi] PST - ppublish SO - Eur J Oncol Nurs. 2022 Oct;60:102171. doi: 10.1016/j.ejon.2022.102171. Epub 2022 Jul 11.