Department of Pharmacy, The IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan.
Division of Frontier Surgery, The Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan.
BMC Gastroenterol. 2022 Jul 14;22(1):341. doi: 10.1186/s12876-022-02411-w.
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.
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.
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.
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.
中等强度外用皮质类固醇预防卡培他滨所致手足综合征（HFS）的临床疗效证据有限。尽管 HFS 的发病机制尚不清楚，但炎症反应被认为与 HFS 的发生有关。本研究旨在评估中等强度外用皮质类固醇（丁酸氢化可的松 0.1%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发生卡培他滨诱导的 HFS 的预防作用。
这是一项单中心、单臂、2 期研究。入组接受卡培他滨联合奥沙利铂辅助化疗的结直肠癌患者，并在标准保湿治疗的基础上预防性应用丁酸氢化可的松 0.1%。主要终点是 3 个月内发生≥2 级 HFS 的发生率。次要终点包括 HFS 发病时间、剂量减少率、方案延迟率、因卡培他滨诱导的 HFS 而停药率以及其他不良事件。所有不良事件均由临床药师和主治医生进行评估。
本研究有望为预防 HFS 的新辅助治疗提供依据，不仅适用于接受辅助化疗的结直肠癌患者，也适用于接受卡培他滨为基础化疗的各种癌症患者。
本试验在日本临床试验注册中心（jRCT）注册，注册号为 jRCTs031220002。注册日期 2022 年 4 月 5 日，网址：https://jrct.niph.go.jp/search。方案版本 V.1.0，2022 年 2 月 16 日。
