Yeo Seung Mi, Lim Ji Young, Kim Seok Won, Chae Byung Joo, Yu Jonghan, Ryu Jai Min, Hwang Ji Hye
Department of Rehabilitation Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Korea.
Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.
J Breast Cancer. 2023 Apr;26(2):93-104. doi: 10.4048/jbc.2023.26.e11. Epub 2023 Mar 13.
This study aimed to investigate the differences in sleep disturbance changes between patients receiving two hormone therapies ("tamoxifen plus ovarian function suppression group [T+OFS group]" versus "tamoxifen group [T group]") and the chronological changes in sleep disturbances in each group.
Premenopausal women with unilateral breast cancer who underwent surgery and were scheduled to receive hormone therapy (HT) with tamoxifen alone or with tamoxifen plus gonadotropin-releasing hormone (GnRH) agonist for ovarian function suppression were included. The enrolled patients wore an actigraphy watch for two weeks and completed questionnaires (insomnia, sleep quality, physical activity [PA], and quality of life [QOL]) at five time points: immediately before HT and 2, 5, 8, and 11 months after HT.
Among the 39 enrolled patients (21 and 18 patients in the T+OFS group and T group, respectively), 25 (17 and 8 patients in the T+OFS group and T group, respectively) were finally analyzed. There were no differences between the two groups in time-dependent changes in insomnia, sleep quality, total sleep time, rapid eye movement sleep rate, QOL, and PA; however, the severity of hot flashes was significantly higher in the T+OFS group than in the T group. Although the interaction between group and time was not significant, insomnia and sleep quality significantly worsened at 2-5 months of HT when changes over time were analyzed within the T+OFS group. In both the groups, PA and QOL were maintained without significant changes.
Unlike tamoxifen alone, tamoxifen plus GnRH agonist initially worsened insomnia and sleep quality, but gradually improved with long-term follow-up. Patients who initially experience insomnia during tamoxifen plus GnRH agonist administration can be reassured based on the results of this study, and active supportive care may be used during this period.
ClinicalTrials.gov Identifier: NCT04116827.
本研究旨在调查接受两种激素疗法（“他莫昔芬加卵巢功能抑制组[T+OFS组]”与“他莫昔芬组[T组]”）的患者在睡眠障碍变化方面的差异，以及每组睡眠障碍的时间变化情况。
纳入接受手术且计划单独使用他莫昔芬或使用他莫昔芬加促性腺激素释放激素（GnRH）激动剂进行卵巢功能抑制的激素治疗（HT）的绝经前单侧乳腺癌女性。入选患者佩戴活动记录仪手表两周，并在五个时间点完成问卷（失眠、睡眠质量、身体活动[PA]和生活质量[QOL]）：HT前即刻以及HT后2、5、8和11个月。
在39名入选患者中（T+OFS组21例，T组18例），最终分析了25例（T+OFS组17例，T组8例）。两组在失眠、睡眠质量、总睡眠时间、快速眼动睡眠率、QOL和PA的时间依赖性变化方面无差异；然而，T+OFS组潮热的严重程度显著高于T组。虽然组与时间之间的交互作用不显著，但在T+OFS组内分析随时间的变化时，HT后2 - 5个月失眠和睡眠质量显著恶化。在两组中，PA和QOL均保持稳定，无显著变化。
与单独使用他莫昔芬不同，他莫昔芬加GnRH激动剂最初会使失眠和睡眠质量恶化，但长期随访后会逐渐改善。基于本研究结果，在他莫昔芬加GnRH激动剂给药期间最初经历失眠的患者可以放心，在此期间可采用积极的支持性护理。
ClinicalTrials.gov标识符：NCT04116827。
