Topical steroid versus placebo for the prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiotherapy: the study protocol of J-SUPPORT 1602 (TOPICS study), a randomized double-blinded phase 3 trial

• Published in: BMC cancer 2018-09, Vol.18 (1), p.873-873, Article 873
• Main Authors: Zenda, Sadamoto, Yamaguchi, Takuhiro, Yokota, Tomoya, Miyaji, Tempei, Mashiko, Tomoe, Tanaka, Mari, Yonemura, Masahito, Takeno, Misaki, Okano, Tomoka, Kawasaki, Toshikatsu, Nakamori, Yuko, Ishii, Shinobu, Shimada, Sanae, Kanamaru, Miyuki, Uchitomi, Yosuke
• Format: Article
• Language: English
• Subjects: Administration, Topical; Analysis; Breast cancer; Cancer patients; Cancer therapies; Care and treatment; Chemoradiotherapy; Chemoradiotherapy - adverse effects; Chemoradiotherapy - methods; Chemotherapy; Clinical Protocols; Clinical trials; Clinical Trials, Phase III as Topic; Comparative analysis; Dermatitis; Dosage and administration; Head & neck cancer; Head and neck; Head and Neck Neoplasms - complications; Head and Neck Neoplasms - therapy; Health aspects; Humans; Multicenter Studies as Topic; Nursing; Nursing care; Placebos; Radiation; Radiation dermatitis; Radiation therapy; Radiodermatitis - diagnosis; Radiodermatitis - etiology; Radiodermatitis - prevention & control; Radiotherapy; Randomized Controlled Trials as Topic; Research Design; Steroid hormones; Steroids; Steroids - administration & dosage; Study Protocol; Topical drugs; Topical steroid
• ISSN: 1471-2407; 1471-2407
• 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.