UMIN-CTR Clinical Trial

Basic information
Public title	Study on prevention of severe oral mucositis for head and neck cancer patients with radiotherapy
Acronym	Study on prevention of severe oral mucositis for head and neck cancer patients with radiotherapy
Scientific Title	Study on prevention of severe oral mucositis for head and neck cancer patients with radiotherapy
Scientific Title:Acronym	Study on prevention of severe oral mucositis for head and neck cancer patients with radiotherapy
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Oral mucositis of patients undergoing current radiotherapy with chemotherapy or cetuximab with head and neck cancer and NCI-CTCAE ver. 3 was determined using NCI-CTCAE ver. 3, and at the time of the onset of grade 1, Lindelon VG dissolved with olive oil Apply to the oral mucosa and investigate whether it can prevent severe grade 3.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Grade 3 Incidence of severe oral mucositis
Key secondary outcomes	Completion rate of CRT and BRT

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	When grade 1 oral mucositis develops, apply Lindelon VG ointment dissolved with olive oil. The application should be four times a day, after breakfast, after lunch, after dinner, before going to bed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Gender: no questions Hospitalization / outpatient: no question
Key exclusion criteria	Patient who is difficult to visit Nagasaki University Hospital Perioperative Oral Administration Center after treatment. Patients with radiation dose of 50 Gy or less.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Sakiko Middle name Last name Soutome
Organization	Nagasaki University Hospital
Division name	Perioperative Oral Management Center
Zip code	852-858
Address	1-7-1 Sakamoto Nagasaki
TEL	095-819-7698
Email	sakiko@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Sakiko Middle name Last name Soutome
Organization	Nagasaki University Hospital
Division name	Perioperative Oral Management Center
Zip code	852-8588
Address	1-7-1 Sakamoto Nagasaki
TEL	095-819-7698
Homepage URL
Email	sakiko@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Nagasaki University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki Unviversity Hospital
Address	Sakamoto
Tel	095-819-7698
Email	gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 01 Day
Date of IRB	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 09 Month 10 Day
Last follow-up date	2019 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 24 Day
Last modified on	2020 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032982