UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030666 |
|---|---|
| Receipt number | R000035009 |
| Scientific Title | Efficacy of spraying with Biotene mouthwash for dry mouth in patients treated with radiochemotherapy for head and neck cancer |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2020/05/28 14:02:05 |
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Basic information
Public title
Efficacy of spraying with Biotene mouthwash for dry mouth in patients treated with radiochemotherapy for head and neck cancer
Acronym
Efficacy of spraying with Biotene mouthwash for dry mouth in patients treated with radiochemotherapy for head and neck cancer
Scientific Title
Efficacy of spraying with Biotene mouthwash for dry mouth in patients treated with radiochemotherapy for head and neck cancer
Scientific Title:Acronym
Efficacy of spraying with Biotene mouthwash for dry mouth in patients treated with radiochemotherapy for head and neck cancer
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine the efficacy of spraying with Biotene mouthwash on radiochemotherapy-induced oral mucositis,xerostomia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measured value by oral moisture meter"MUCUS"
Key secondary outcomes
Subjective symptom
The humidity
4 items of mouth dryness according to OAG classification
Number of spraying with Biotene mouthwash
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Spraying with Biotene mouthwash is performed simultaneously with radiochemotherapy.
And oral moisture is measured by MUCUS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients treated with radiochemotherapy for head and neck cancer
2. Patients who agree to the study
Key exclusion criteria
1. Patients judged by the primary doctor as inappropriate
2. Patients who disagree to the study
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Iwata |
Organization
Uwajima City Hospital
Division name
Department of Nursing
Zip code
7988510
Address
1-1,Goten-machi,Uwajima
TEL
0895-25-1111
aya-su@uwajima-mh.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Iwata |
Organization
Uwajima City Hospital
Division name
Department of Nursing
Zip code
7988510
Address
1-1,Goten-machi,Uwajima
TEL
0895-25-1111
Homepage URL
aya-su@uwajima-mh.jp
Sponsor or person
Institute
Uwajima City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
UwajimaCityHospital
Address
1-1,Goten-machi,Uwajima
Tel
0895-25-1111
aya-su@uwajima-mh.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
| 2018 | Year | 02 | 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
2
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
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 03 | Day |
Last modified on
| 2020 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035009
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
