Auricular acupressure for nausea and vomiting in breast cancer: Feasibility outcomes from a Phase II trial with embedded qualitative insights

IF 1.9 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-04-23 DOI:10.1016/j.eujim.2025.102484

Jing-Yu (Benjamin) Tan , Lorna K.P. Suen , Tao Wang

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引用次数: 0

Abstract

Introduction

Auricular acupressure (AA) has been a popular complementary health approach for managing cancer-related symptoms, including chemotherapy-induced nausea and vomiting (CINV) in breast cancer (BC) patients. Despite its growing use, clinical evidence regarding the feasibility and acceptability of AA remains limited and not yet fully established. This study aims to evaluate the feasibility and acceptability of using an evidence-based AA intervention for managing CINV in BC patients.

Methods

This paper reports the feasibility outcomes from a Phase II randomised controlled trial (RCT) with embedded qualitative insights. The clinical trial equally assigned 114 participants to a true AA, placebo AA, or standard care group. Patient-reported outcomes were assessed using the MASCC Antiemesis Tool (MAT), the Index of Nausea, Vomiting, and Retching (INVR), and the Functional Assessment of Cancer Therapy-Breast (FACT-B). Study feasibility was evaluated through recruitment, implementation, outcome assessment, intervention feasibility and safety, and participants’ satisfaction. Upon RCT completion, semi-structured interviews were conducted to explore participants’ experiences with the RCT and the intervention.

Results

The RCT achieved a high completion with 110 participants. Most participants adhered strictly to the 5-day AA protocol. AA-related adverse events were mild and transient. Participants found the complementary healthcare approaches convenient and safe, reporting that the study questionnaires were easy to complete and effectively captured CINV symptoms using MAT. Most participants supported AA's benefits in managing CINV.

Conclusion

The RCT procedures for using AA to manage CINV in BC patients were feasible, with satisfactory recruitment and retention rates, good questionnaire acceptability, and adherence to the protocol. Qualitative findings enhanced understanding of RCT feasibility and protocol acceptability from patients' perspectives. Findings from the Phase II RCT and qualitative interviews supported AA as a safe and convenient intervention for a future Phase III RCT to evaluate its definite effects on CINV in BC patients.

Clinical Trial Registration

ClinicalTrial.Gov (NCT02403037).

查看原文本刊更多论文

耳穴按摩治疗乳腺癌患者的恶心和呕吐：一项具有嵌入定性见解的II期试验的可行性结果

耳穴按压（AA）一直是一种流行的辅助健康方法，用于治疗癌症相关症状，包括乳腺癌（BC）患者化疗引起的恶心和呕吐（CINV）。尽管它的使用越来越多，但关于AA的可行性和可接受性的临床证据仍然有限，尚未完全建立。本研究旨在评估使用循证AA干预治疗BC患者CINV的可行性和可接受性。方法本文报告了一项具有嵌入定性见解的II期随机对照试验（RCT）的可行性结果。临床试验将114名参与者平均分配到真正的AA组、安慰剂AA组和标准护理组。采用MASCC止吐工具（MAT）、恶心、呕吐和干呕指数（INVR）和乳腺癌治疗功能评估（FACT-B）对患者报告的结果进行评估。通过招募、实施、结局评估、干预的可行性和安全性、参与者满意度来评估研究的可行性。在RCT完成后，进行半结构化访谈，以探讨参与者对RCT和干预的体验。结果随机对照试验有110人，完成率较高。大多数参与者严格遵守5天AA协议。aa相关不良事件轻微且短暂。参与者发现补充医疗保健方法方便和安全，报告说研究问卷易于完成，并使用MAT有效地捕获CINV症状。大多数参与者支持AA在管理CINV方面的益处。结论使用AA治疗BC患者CINV的RCT程序是可行的，具有令人满意的招募率和保留率，良好的问卷可接受性和方案依从性。定性研究结果从患者的角度增强了对RCT可行性和方案可接受性的理解。II期RCT和定性访谈的结果支持AA作为一种安全、方便的干预措施，用于未来的III期RCT，以评估其对BC患者CINV的确切效果。临床试验注册政府(NCT02403037)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

4.70

自引率

4.00%

发文量

102

审稿时长

33 days

期刊介绍： The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.