Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, 5-1-1 Tukiji Chuoku Tokyo, Japan.
Department of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa Chiba, 277-8577, Japan.
BMC Cancer. 2018 Sep 6;18(1):873. doi: 10.1186/s12885-018-4763-1.
To date, the clinical benefit of topical steroid use has only been demonstrated for radiation dermatitis induced by 50-60 Gy irradiation in breast cancer. However, these agents are also often used clinically for the control of radiation dermatitis induced by high-dose (>60Gy) irradiation with chemotherapy in head and neck cancer. Despite this, the prophylactic efficacy of topical steroids for radiation dermatitis induced by high-dose irradiation is still unclear. The aim of this study is to clarify the benefit of topical steroids in basic nursing care for radiation dermatitis induced by chemoradiotherapy in patients with head and neck cancer.
The study is being conducted as a multicenter 2-arm randomized double-blinded placebo-controlled Phase 3 trial in Japan. The study was started in May 2017, with participant enrollment between May 2017 and April 2019. Patients scheduled to receive definitive or postoperative chemoradiotherapy for head and neck cancer are eligible for enrollment. All patients will receive chemoradiotherapy, consisting of single agent CDDP and 70-Gy irradiation. Bilateral neck irradiation is mandatory. Supportive care for radiation dermatitis will consist of basic nursing care with topical steroid or placebo. When radiation dermatitis grade 1 is seen or total radiation dose reaches 30 Gy, minimally required intervention will be started as a first step. If radiation dermatitis worsens to grade 2, the irradiated area will be covered with a moderately absorbent surgical pad and steroid or placebo topical cream. The primary endpoint is a comparison of the proportion of patients with ≥ grade 2 radiation dermatitis by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Ethical approval has been obtained from all participating sites. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.
Evidence supporting the benefit of adding topical steroids in general nursing care for radiation dermatitis induced by high-dose irradiation with chemotherapy is insufficient. This trial aims to clarify the clinical benefit of topical steroid for radiation dermatitis induced by high-dose irradiation with chemotherapy. The trial is ongoing and is currently recruiting.
UMIN000027161 . Protocol version 3.0, 18 April 2017.
迄今为止，局部皮质类固醇的临床益处仅在乳腺癌 50-60Gy 照射诱导的放射性皮炎中得到证实。然而，这些药物在临床中也常用于控制头颈部癌症中高剂量 (>60Gy) 照射联合化疗诱导的放射性皮炎。尽管如此，高剂量照射诱导的放射性皮炎中局部皮质类固醇的预防效果仍不清楚。本研究旨在阐明局部皮质类固醇在头颈部癌症放化疗诱导的放射性皮炎基础护理中的作用。
本研究是在日本进行的一项多中心、2 臂、随机、双盲、安慰剂对照的 3 期试验。研究于 2017 年 5 月启动，2017 年 5 月至 2019 年 4 月期间招募参与者。符合条件的患者为计划接受头颈部癌症根治性或术后放化疗的患者。所有患者将接受包含单药顺铂和 70Gy 照射的放化疗。双侧颈部照射是强制性的。放射性皮炎的支持性护理将包括局部皮质类固醇或安慰剂的基础护理。当观察到放射性皮炎 1 级或总放射剂量达到 30Gy 时，将作为第一步开始进行最小干预。如果放射性皮炎恶化至 2 级，将用中度吸水性手术垫覆盖照射区域，并涂抹皮质类固醇或安慰剂的局部乳膏。主要终点是比较根据 NCI 不良事件通用术语标准 (CTCAE) 第 4.0 版评估的 ≥2 级放射性皮炎患者的比例。所有参与单位均已获得伦理批准。本研究的结果将提交给国际同行评议期刊发表，并将在国际科学会议上报告关键发现。
支持在高剂量照射联合化疗诱导的放射性皮炎中常规护理中添加局部皮质类固醇的证据不足。本试验旨在阐明高剂量照射联合化疗诱导的放射性皮炎中局部皮质类固醇的临床益处。该试验正在进行中，目前正在招募参与者。
UMIN000027161。方案版本 3.0，2017 年 4 月 18 日。
