Yamamoto Kazuhiro, Ioroi Takeshi, Harada Kenichi, Nishiyama Satoshi, Nishigori Chikako, Yano Ikuko
Department of Pharmacy, Kobe University Hospital, Kobe, Japan.
Department of Urology, Graduate School of Medicine, Kobe University, Kobe, Japan.
JMIR Res Protoc. 2019 Aug 12;8(8):e14636. doi: 10.2196/14636.
Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple-tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life and is associated with the therapeutic efficacy of multiple-TKIs. Therefore, the management and prevention of HFSR is an important issue; however, an effective method for its prevention has not been established. Specific ascorbic acid derivatives can reverse multiple-TKI-induced keratinocyte growth and pathological changes in vitro.
This study was designed to evaluate the safety of bis-glyceryl ascorbate (Amitose DGA), a novel, hydrosoluble, and moisturizing ascorbic acid derivative, in patients with renal cell carcinoma (RCC) receiving sunitinib therapy. This study was also designed to evaluate Amitose DGA's preventive efficacy for sunitinib-induced HFSR.
This is a Phase I/II, single-center, uncontrolled, single-arm, open-label trial. We will recruit a total of 30 patients with RCC receiving sunitinib therapy, with a 2-week-on and 1-week-off schedule. The participants will apply Amitose DGA-containing cream over both palmar and plantar surfaces within two treatment cycles (ie, 6 weeks) of sunitinib in combination with a general moisturizing agent, in addition to standard-of-care processes. Safety assessments will include dermatological abnormalities, clinical laboratory tests, and incidence of adverse events. Efficacy assessments will include development of HFSR and therapeutic outcomes associated with sunitinib.
Recruitment to the study began in August 2017 and is ongoing in Japan. To date, 21 subjects have been recruited. Study completion is expected in 2021.
This is the first clinical study of Amitose DGA-containing cream in patients with RCC who are receiving sunitinib therapy. The single-center, single-arm, open-label design was selected to maximize subject exposure and increase the likelihood of achieving our study endpoints. The results will provide valuable and preliminary evidence of the effects of Amitose DGA-containing cream on HFSR.
UMIN Clinical Trials Registry UMIN000027209; https://upload.umin.ac.jp/cgi-open-bin/ctr /ctr_view.cgi?recptno=R000031174.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14636.
手足皮肤反应（HFSR）是多种酪氨酸激酶抑制剂（TKIs）引起的严重副作用。HFSR可导致治疗中断或剂量减少。HFSR还会显著降低生活质量，并与多种TKIs的治疗效果相关。因此，HFSR的管理和预防是一个重要问题；然而，尚未建立有效的预防方法。特定的抗坏血酸衍生物可在体外逆转多种TKI诱导的角质形成细胞生长和病理变化。
本研究旨在评估新型水溶性保湿抗坏血酸衍生物双甘油抗坏血酸酯（Amitose DGA）在接受舒尼替尼治疗的肾细胞癌（RCC）患者中的安全性。本研究还旨在评估Amitose DGA对舒尼替尼诱导的HFSR的预防效果。
这是一项I/II期单中心、非对照、单臂、开放标签试验。我们将总共招募30例接受舒尼替尼治疗且采用2周用药、1周停药方案的RCC患者。参与者将在舒尼替尼治疗的两个周期（即6周）内，除了标准护理流程外，在手掌和足底表面涂抹含Amitose DGA的乳膏，并联合使用一般保湿剂。安全性评估将包括皮肤异常、临床实验室检查和不良事件发生率。疗效评估将包括HFSR的发生情况以及与舒尼替尼相关的治疗结果。
该研究于2017年8月开始招募，目前在日本仍在进行中。迄今为止，已招募21名受试者。预计2021年完成研究。
这是第一项关于含Amitose DGA乳膏在接受舒尼替尼治疗的RCC患者中的临床研究。选择单中心、单臂、开放标签设计以最大限度地增加受试者暴露并提高实现研究终点的可能性。研究结果将为含Amitose DGA乳膏对HFSR的作用提供有价值的初步证据。
UMIN临床试验注册中心UMIN000027209；https://upload.umin.ac.jp/cgi-open-bin/ctr /ctr_view.cgi?recptno=R000031174。
国际注册报告识别码（IRRID）：DERR1-10.2196/14636。
