UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011254 |
|---|---|
| Receipt number | 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 | 2022/06/08 15:36:28 |
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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
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
Public contact
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
yumiko-t@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013191
