■许多乳腺癌患者担心癌症复发(FCR)。然而,对FCR的有效身体干预一直很少。先前的研究已经证实,重复经颅磁刺激(rTMS)可以帮助改善患者的焦虑,抑郁症,恐惧,和压力水平。因此,本研究旨在评估rTMS治疗乳腺癌患者FCR的疗效,并探讨其潜在的神经机制。
■和分析:50例高FCR的乳腺癌患者(FCR总分>27),将招募50名年龄和性别匹配的低FCR患者(FCR总分<7)参加本研究。高FCR组的患者将被随机分配接受为期4周的针对右背外侧前额叶皮质(rDLPFC)的低频rTMS+照常治疗(TAU)(n=25),或接受假刺激+TAU(n=25)。低FCR组的患者将仅接受TAU。所有参与者将进行基线fMRI扫描,以检查前额叶皮层(DLPFC)之间的局部活动和大脑活动的相互作用,杏仁核和海马体.对癌症复发的恐惧问卷(FCRQ7),患者健康问卷(PHQ9),广义焦虑症(GAD7),数字评级量表(NRS),失眠严重程度指数(ISI7)将用于衡量个人的FCR,抑郁症,焦虑,疼痛,和失眠症状在第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)。高FCR组的参与者将在干预后24小时内接受治疗后fMRI扫描,以探讨rTMS治疗的神经机制。这项研究的主要结果,rTMS干预是否足以缓解乳腺癌患者的FCR,由FCRQ7测量。此外,任务激活,DLPFC的本地活动和功能连接,杏仁核和海马体进行比较,在高和低FCR组之间,治疗前后。
■研究表明,低频rTMS可用于治疗患者的FCR。然而,缺乏相关证据支持rTMS对癌症患者FCR的疗效,rTMS对FCR影响的神经机制有待进一步研究。
■本研究已获得广东省人民医院伦理委员会的伦理批准(参考编号:KY-N-2022-136-01)。调查结果将发表在科学论文中。如有必要,调查数据将在线提供。
■NCT05881889(ClinicalTrials.gov)。注册日期:2023年5月31日。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: NCT05881889 (ClinicalTrials.gov). Date of registration: May 31, 2023.