Pharmaceutical Department, Ageo Central General Hospital, Ageo, Japan.
Division of Applied Pharmaceutical Education and Research, Hoshi University, Shinagawa-ku, Japan
BMJ Open. 2023 Sep 14;13(9):e071500. doi: 10.1136/bmjopen-2022-071500.
Symptom-related adverse events associated with perioperative chemotherapy in patients with breast cancer include short-term adverse events such as nausea and vomiting. However, changes in the severity and duration of prolonged symptom-related adverse events have not been fully investigated. We present a protocol of a study that aims to clarify the prevalence of symptom-related adverse events in patients with breast cancer 1 year after neoadjuvant or adjuvant chemotherapy using an electronic patient-reported outcomes (ePRO) system.
This multicentre prospective observational cohort study will include patients with breast cancer who have received preoperative or postoperative adjuvant chemotherapy. The final injection date of the cytotoxic agent will be the study initiation date. Patients will report every 2 weeks from the initiation date to 12 weeks and every 4 weeks from 12 weeks to 1 year, and they can enter this information into the ePRO system from anywhere. The primary outcome will be the prevalence of symptom-related adverse events according to the ePRO system 1 year after the date of the last injection of the cytotoxic drug used in neoadjuvant or adjuvant chemotherapy for breast cancer. To increase multi-institutional enrolment, two cohorts will be included. Cohort 1 will comprise patients with acquisition of baseline patient information regarding preoperative chemotherapy and presurgery characteristics. Cohort 2 will comprise patients without acquisition of baseline patient information. The target sample size is ≥250 per year.
The study protocol has been approved by the ethics committee at each participating institution. The results will be presented at major national and international conferences and submitted to peer-reviewed journals.
Registration was started in October 2021. By August 2022, a total of 132 participants were enrolled. Follow-up will be continued through December 2024.
UMIN000045422.
与乳腺癌患者围手术期化疗相关的症状相关不良事件包括短期不良事件，如恶心和呕吐。然而，长期症状相关不良事件的严重程度和持续时间的变化尚未得到充分研究。我们提出了一项研究方案，旨在使用电子患者报告结局（ePRO）系统阐明接受新辅助或辅助化疗的乳腺癌患者在化疗后 1 年时症状相关不良事件的发生率。
这是一项多中心前瞻性观察队列研究，将包括接受术前或术后辅助化疗的乳腺癌患者。细胞毒性药物的最后一次注射日期将作为研究起始日期。患者将从起始日期开始每 2 周报告一次，持续 12 周，然后每 4 周报告一次，从 12 周持续到 1 年，并且他们可以从任何地方将这些信息输入 ePRO 系统。主要结局将是根据 ePRO 系统，在新辅助或辅助化疗结束后 1 年时，接受乳腺癌新辅助或辅助化疗的最后一次细胞毒性药物注射后 1 年时症状相关不良事件的发生率。为了增加多机构的参与，将包括两个队列。队列 1 将包括获得术前化疗和术前特征的基线患者信息的患者。队列 2 将包括未获得基线患者信息的患者。目标样本量为每年≥250 例。
该研究方案已获得每个参与机构的伦理委员会的批准。研究结果将在主要的国内和国际会议上公布，并提交给同行评议的期刊。
注册于 2021 年 10 月开始。截至 2022 年 8 月，共有 132 名参与者入组。随访将持续到 2024 年 12 月。
UMIN000045422。
