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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011254
Receipt No. R000013191
Scientific Title Prophylaxis of radiation-induced oral mucositis in oral cancer patients: multicenter randomized clinical trial
Date of disclosure of the study information 2013/07/24
Last modified on 2013/12/03

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Basic information
Public title Prophylaxis of radiation-induced oral mucositis in oral cancer patients: multicenter randomized clinical trial
Acronym Prophylaxis of RT-induced oral mucositis
Scientific Title Prophylaxis of radiation-induced oral mucositis in oral cancer patients: multicenter randomized clinical trial
Scientific Title:Acronym Prophylaxis of RT-induced oral mucositis
Region
Japan

Condition
Condition oral cancer
Classification by specialty
Radiology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To demonstrate that oral managemet prevents severe oral mucositis during radiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes severe oral mucositis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Interventions: oral care and oral management (preparation of spacers, administer of pilocarpine hydrochloride, use of olive oil-based steroid ointment) during radiotherapy.
during the three year study period
Interventions/Control_2 Control: oral care during radiotherapy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria oral cancer patients with radiotherapy
Key exclusion criteria patients who did not agree with this study
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yumiko Kawashita
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Oral Health
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Yumiko Kawashita
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Oral Health
Zip code
Address
TEL
Homepage URL
Email yumiko-t@nagasaki-u.ac.jp

Sponsor
Institute Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2013 Year 07 Month 24 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 05 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
2013 Year 07 Month 23 Day
Last modified on
2013 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013191

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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