Effects of repetitive transcranial magnetic stimulation on fear of cancer recurrence and its underlying neuromechanism

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-04-23 DOI:10.1016/j.conctc.2024.101299
Wenjing Xu , Na Zhao , Wengao Li , Lirong Qiu , Xian Luo , Yuanyuan Lin , Wenjing Wang , Samradhvi Garg , Hengwen Sun , Yuan Yang
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Abstract

Introduction

Many breast cancer patients suffer from fear of cancer recurrence (FCR). However, effective physical intervention for FCR has been scarce. Previous studies have confirmed that repetitive transcranial magnetic stimulation (rTMS) can help improve patients' anxiety, depression, fear, and stress level. Therefore, this study aims to assess the efficacy of rTMS in the treatment of FCR in breast cancer patients and explore its underlying neural mechanism.

Methods and analysis

and analysis: Fifty breast cancer patients with high FCR (FCR total score >27), and fifty age- and gender-matched patients with low FCR (FCR total score <7) will be recruited to participate in this study. Patients in the high FCR group will be randomly assigned to receive 4-week low-frequency rTMS targeting the right dorsolateral prefrontal cortex (rDLPFC) + treatment as usual (TAU) (n = 25), or to receive sham stimulation + TAU (n = 25). Patients in the low FCR group will only receive TAU. All participants will take a baseline fMRI scan to examine the local activities and interactions of brain activity between the prefrontal cortex (DLPFC), amygdala and hippocampus. Fear of Cancer Recurrence Questionnaire (FCRQ7), Patient Health Questionnaire (PHQ9), Generalize Anxiety Disorder (GAD7), Numeric Rating Scale (NRS), and Insomnia Severity Index (ISI7) will be used to measure an individual's FCR, depression, anxiety, pain, and insomnia symptoms at week 0 (baseline), week 4 (the end of intervention), week 5 (1 week post-treatment), week 8 (1 month post-treatment), and week 16 (3 months post-treatment). Participants in the high FCR group will receive a post-treatment fMRI scan within 24 h after intervention to explore the neural mechanisms of rTMS treatment. The primary outcome of the study, whether the rTMS intervention is sufficient in relieving FCR in breast cancer patients, is measured by FCRQ7. Additionally, task activation, local activity and functional connectivity of the DLPFC, amygdala and hippocampus will be compared, between high and low FCR group, and before and after treatment.

Discussion

Studies have shown that low-frequency rTMS can be used to treat patient's FCR. However, there is a lack of relevant evidence to support the efficacy of rTMS on FCR in cancer patients, and the neural mechanisms underlying the effects of rTMS on FCR need to be further investigated.

Ethics and dissemination

Ethical approval for the study has been obtained from the Ethics Committee of Guangdong Provincial People's Hospital (reference number: KY-N-2022-136-01). The results of the investigation will be published in scientific papers. The data from the investigation will be made available online if necessary.

Trial registration

NCT05881889 (ClinicalTrials.gov). Date of registration: May 31, 2023.

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重复经颅磁刺激对癌症复发恐惧及其潜在神经机制的影响
导言:许多乳腺癌患者都患有癌症复发恐惧症(FCR)。然而,针对癌症复发恐惧的有效物理干预措施却很少见。以往的研究证实,重复经颅磁刺激(rTMS)有助于改善患者的焦虑、抑郁、恐惧和压力水平。因此,本研究旨在评估经颅磁刺激治疗乳腺癌患者FCR的疗效,并探讨其潜在的神经机制:本研究将招募 50 名高 FCR(FCR 总分 27 分)乳腺癌患者和 50 名年龄和性别匹配的低 FCR(FCR 总分 7 分)患者。高FCR组患者将被随机分配接受为期4周的针对右侧背外侧前额叶皮层(rDLPFC)的低频经颅磁刺激+常规治疗(TAU)(n = 25),或接受假刺激+TAU(n = 25)。低FCR组患者只接受TAU治疗。所有参与者都将接受基线 fMRI 扫描,以检查大脑前额叶皮层(DLPFC)、杏仁核和海马之间的局部活动和相互作用。癌症复发恐惧问卷(FCRQ7)、患者健康问卷(PHQ9)、广泛性焦虑症(GAD7)、数字评定量表(NRS)和失眠严重程度指数(ISI7)将用于测量个体的 FCR、在第 0 周(基线)、第 4 周(干预结束)、第 5 周(治疗后 1 周)、第 8 周(治疗后 1 个月)和第 16 周(治疗后 3 个月),将分别测量个人的 FCR、抑郁、焦虑、疼痛和失眠症状。高 FCR 组的参与者将在干预后 24 小时内接受治疗后 fMRI 扫描,以探索经颅磁刺激治疗的神经机制。研究的主要结果,即经颅磁刺激干预是否足以缓解乳腺癌患者的 FCR,将通过 FCRQ7 进行测量。此外,还将比较高FCR组和低FCR组以及治疗前后DLPFC、杏仁核和海马的任务激活、局部活动和功能连接。伦理与传播本研究已获得广东省人民医院伦理委员会的伦理批准(编号:KY-N-2022-136-01)。调查结果将在科学论文中发表。必要时,调查数据将在网上公布。试验注册号:NCT05881889(ClinicalTrials.gov)。注册日期:2023 年 5 月 31 日:注册日期:2023 年 5 月 31 日。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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