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
Abstract Background 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)...
Main Authors: | , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2018-09-01
|
Series: | BMC Cancer |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s12885-018-4763-1 |
id |
doaj-cd9cc5b8f20542caa6555ef914a2650a |
---|---|
record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Sadamoto Zenda Takuhiro Yamaguchi Tomoya Yokota Tempei Miyaji Tomoe Mashiko Mari Tanaka Masahito Yonemura Misaki Takeno Tomoka Okano Toshikatsu Kawasaki Yuko Nakamori Shinobu Ishii Sanae Shimada Miyuki Kanamaru Yosuke Uchitomi |
spellingShingle |
Sadamoto Zenda Takuhiro Yamaguchi Tomoya Yokota Tempei Miyaji Tomoe Mashiko Mari Tanaka Masahito Yonemura Misaki Takeno Tomoka Okano Toshikatsu Kawasaki Yuko Nakamori Shinobu Ishii Sanae Shimada Miyuki Kanamaru Yosuke Uchitomi 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 BMC Cancer Head and neck Chemoradiotherapy Radiation dermatitis Nursing Topical steroid |
author_facet |
Sadamoto Zenda Takuhiro Yamaguchi Tomoya Yokota Tempei Miyaji Tomoe Mashiko Mari Tanaka Masahito Yonemura Misaki Takeno Tomoka Okano Toshikatsu Kawasaki Yuko Nakamori Shinobu Ishii Sanae Shimada Miyuki Kanamaru Yosuke Uchitomi |
author_sort |
Sadamoto Zenda |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2018-09-01 |
description |
Abstract Background 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. Methods 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. Discussion 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. Trial registration number UMIN000027161. Protocol version 3.0, 18 April 2017. |
topic |
Head and neck Chemoradiotherapy Radiation dermatitis Nursing Topical steroid |
url |
http://link.springer.com/article/10.1186/s12885-018-4763-1 |
work_keys_str_mv |
AT sadamotozenda topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT takuhiroyamaguchi topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT tomoyayokota topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT tempeimiyaji topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT tomoemashiko topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT maritanaka topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT masahitoyonemura topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT misakitakeno topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT tomokaokano topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT toshikatsukawasaki topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT yukonakamori topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT shinobuishii topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT sanaeshimada topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT miyukikanamaru topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial AT yosukeuchitomi topicalsteroidversusplaceboforthepreventionofradiationdermatitisinheadandneckcancerpatientsreceivingchemoradiotherapythestudyprotocolofjsupport1602topicsstudyarandomizeddoubleblindedphase3trial |
_version_ |
1724878921454845952 |
spelling |
doaj-cd9cc5b8f20542caa6555ef914a2650a2020-11-25T02:19:03ZengBMCBMC Cancer1471-24072018-09-011811610.1186/s12885-018-4763-1Topical 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 trialSadamoto Zenda0Takuhiro Yamaguchi1Tomoya Yokota2Tempei Miyaji3Tomoe Mashiko4Mari Tanaka5Masahito Yonemura6Misaki Takeno7Tomoka Okano8Toshikatsu Kawasaki9Yuko Nakamori10Shinobu Ishii11Sanae Shimada12Miyuki Kanamaru13Yosuke Uchitomi14Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center HospitalDepartment of Clinical Trial Data Management, Graduate School of Medicine, Tohoku UniversityDepartment of Gastrointestinal Oncology, Shizuoka Cancer CenterDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of TokyoSuxac IncDepartment of Radiation Oncology, National Cancer Center Hospital EastDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of TokyoDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of TokyoDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of TokyoDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of TokyoDepartment of Radiation Oncology, National Cancer Center Hospital EastDepartment of Radiation Oncology, National Cancer Center Hospital EastInnovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center HospitalInnovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center HospitalInnovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center HospitalAbstract Background 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. Methods 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. Discussion 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. Trial registration number UMIN000027161. Protocol version 3.0, 18 April 2017.http://link.springer.com/article/10.1186/s12885-018-4763-1Head and neckChemoradiotherapyRadiation dermatitisNursingTopical steroid |