Abstract：
BACKGROUND: Clinical evidence of the preventive effectiveness of medium-class topical corticosteroids for capecitabine-induced hand foot syndrome (HFS) is limited. Although the pathogenesis and mechanism of HFS are unclear, inflammatory reactions are thought to be involved in HFS development. This study aimed to evaluate the preventive effect of medium-class topical corticosteroids (hydrocortisone butyrate 0.1% topical therapy) for capecitabine-induced HFS in patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine plus oxaliplatin.
METHODS: This is a single-center, single-arm, phase 2 study. Patients with colorectal cancer scheduled to receive adjuvant chemotherapy with capecitabine plus oxaliplatin are enrolled, and topical hydrocortisone butyrate 0.1% is applied prophylactically in addition to standard moisturizing therapy. The primary endpoint is the incidence of grade ≥ 2 HFS within three months. The secondary endpoints are the time to onset of HFS, rates of dose reduction, schedule delay, discontinuation caused by capecitabine-induced HFS, and other adverse events. All adverse events are evaluated by clinical pharmacists and attending physicians.
CONCLUSIONS: This study is expected to contribute to the establishment of new supportive care for preventing HFS, not only for colorectal cancer patients receiving adjuvant chemotherapy, but also for various cancer patients receiving capecitabine-based chemotherapy.
BACKGROUND: This trial was registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs031220002. Registered 5 April 2022, https://jrct.niph.go.jp/search Protocol version V.1.0, 16 February 2022.
METHODS: This is a single-center, single-arm, phase 2 study. Patients with colorectal cancer scheduled to receive adjuvant chemotherapy with capecitabine plus oxaliplatin are enrolled, and topical hydrocortisone butyrate 0.1% is applied prophylactically in addition to standard moisturizing therapy. The primary endpoint is the incidence of grade ≥ 2 HFS within three months. The secondary endpoints are the time to onset of HFS, rates of dose reduction, schedule delay, discontinuation caused by capecitabine-induced HFS, and other adverse events. All adverse events are evaluated by clinical pharmacists and attending physicians.
CONCLUSIONS: This study is expected to contribute to the establishment of new supportive care for preventing HFS, not only for colorectal cancer patients receiving adjuvant chemotherapy, but also for various cancer patients receiving capecitabine-based chemotherapy.
BACKGROUND: This trial was registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs031220002. Registered 5 April 2022, https://jrct.niph.go.jp/search Protocol version V.1.0, 16 February 2022.
摘要：
背景：中型外用皮质类固醇对卡培他滨诱发的手足综合征（HFS）的预防效果的临床证据有限。尽管HFS的发病机制尚不清楚,炎症反应被认为与HFS的发生有关.本研究旨在评估中类局部皮质类固醇（0.1％丁酸氢化可的松局部治疗）对接受卡培他滨联合奥沙利铂辅助化疗的结直肠癌患者卡培他滨诱导的HFS的预防作用。
方法：这是一个单中心，单臂,第二阶段研究。纳入计划接受卡培他滨联合奥沙利铂辅助化疗的结直肠癌患者，和局部应用0.1%丁酸氢化可的松，除标准保湿疗法外，预防性应用。主要终点是三个月内≥2级HFS的发生率。次要终点是HFS开始的时间，剂量减少率，时间表延迟，卡培他滨诱导的HFS引起的停药，和其他不良事件。所有不良事件均由临床药师和主治医师进行评估。
结论：这项研究有望为预防HFS的新的支持性治疗提供帮助。不仅适用于结直肠癌患者接受辅助化疗,也适用于各种接受卡培他滨化疗的癌症患者。
背景：该试验在日本临床试验注册中心（jRCT）注册为jRCTs031220002。2022年4月5日注册，https://jrct。尼夫.走吧。jp/search协议版本V.1.0，2022年2月16日。
方法：这是一个单中心，单臂,第二阶段研究。纳入计划接受卡培他滨联合奥沙利铂辅助化疗的结直肠癌患者，和局部应用0.1%丁酸氢化可的松，除标准保湿疗法外，预防性应用。主要终点是三个月内≥2级HFS的发生率。次要终点是HFS开始的时间，剂量减少率，时间表延迟，卡培他滨诱导的HFS引起的停药，和其他不良事件。所有不良事件均由临床药师和主治医师进行评估。
结论：这项研究有望为预防HFS的新的支持性治疗提供帮助。不仅适用于结直肠癌患者接受辅助化疗,也适用于各种接受卡培他滨化疗的癌症患者。
背景：该试验在日本临床试验注册中心（jRCT）注册为jRCTs031220002。2022年4月5日注册，https://jrct。尼夫.走吧。jp/search协议版本V.1.0，2022年2月16日。
