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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028813
Receipt No. R000032982
Scientific Title Study on prevention of severe oral mucositis for head and neck cancer patients with radiotherapy
Date of disclosure of the study information 2017/09/01
Last modified on 2018/12/20

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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
Middle name
Last name Sakiko Soutome
Organization Nagasaki University Hospital
Division name Perioperative Oral Management Center
Zip code
Address 1-7-1 Sakamoto Nagasaki
TEL 095-819-7698
Email sakiko@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakiko Soutome
Organization Nagasaki University Hospital
Division name Perioperative Oral Management Center
Zip code
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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 10 Day
Last follow-up date
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
2018 Year 12 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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