臨床研究等提出・公開システム

Date of registration	Feb. 16, 2024
Last modified on	Feb. 16, 2024
Trial ID	jRCT1020230058

Scientific Title	Development and validation of neck cover for head and neck cancer patients undergoing radiation therapy
Public Title	Development and validation of neck cover for head and neck cancer patients undergoing radiation therapy

Contact for Scientific Queries	Name	Sato Yumiko
	Affiliation	Hirosaki University Hospital
	Address	53,Honcho,Hirosaki-shi,Aomori
	Telephone	+81-172-33-5111
	E-mail	satoyumi@hirosaki-u.ac.jp
Contact for Public Queries	Name	Sato Yumiko
	Affiliation	Hirosaki University Hospital
	Address	53,Honcho,Hirosaki-shi,Aomori
	Telephone	+81-172-33-5111
	E-mail	satoyumi@hirosaki-u.ac.jp

Recruitment status	Pending


Anticipated date of first enrollment		Feb. 16, 2024
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with head and neck cancer undergoing radiation therapy. It has not appeared cervical radiation dermatitis yet or have one with the slight erythema,and the person who gets permission of the use of the neck cover trial product then the chief physician.
	Exclusion Criteria	People with cognitive decline and have difficulty-understanding explanation. People who are incapable of the cervical skin self-care.
	Age Minimum	No limit
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		head and neck cancer tongue cancer oral cancer
Intervention(s)		The subjects the trial product of the neck cover after that, they fill out a questionnaire by the hearing investigation.
Health Condition(s) Keyword		head and neck cancer
Intervention(s) Keyword		neck cover
Primary Outcome(s)		The questionnaires consist of five phases of Rickert scales. We ask sense the touch (quickly), impressions (irritating fewness, suffering, sweltry, easy wearing, ease of taking off, tendency to shift easily) when try on it. In addition, they answer whether they think it is acceptable to use it in patients with cervical dermatitis.
Secondary Outcome(s)		The questions about a problem on using it, a good point, a point to be improved ask for free writing.

Primary Sponsor	Hirosaki University Hospital

Name of Certified Review Board	Hirosaki University Graduate School of Medicine course Ethical Review Board
Address	5,Zaifucho,HIrosaki-shi,Aomori, Aomori
Telephone	+81-172-39-5043
E-Mail	rinri@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 11, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none