UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019179 |
|---|---|
| Receipt number | R000022172 |
| Scientific Title | prophylactic effect and QOL analysis of in gargling with pilocarpine and polaprezinc for radiation-induced xerostomia |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2019/10/03 13:31:31 |
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Basic information
Public title
prophylactic effect and QOL analysis of in gargling with pilocarpine and polaprezinc for radiation-induced xerostomia
Acronym
prophylactic effect and QOL analysis of in gargling with pilocarpine and polaprezinc for radiation-induced xerostomia
Scientific Title
prophylactic effect and QOL analysis of in gargling with pilocarpine and polaprezinc for radiation-induced xerostomia
Scientific Title:Acronym
prophylactic effect and QOL analysis of in gargling with pilocarpine and polaprezinc for radiation-induced xerostomia
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to analyze prophylactic effect and QOL of gargling with pirocarpine and polaprezinc for raidation-induced xarostomia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
alteration in oral QOL score, saliva production and gustatory sense.
Key secondary outcomes
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
gargling with pirocarpine and polaprezinc since starting radiotherapy to 1 month after radiotherapy
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients who will be treated with radiotherapy for head and neck cancer
2. mean irradiated dose for protid grand is more than 20 Gy
3. PS(ECOG)=0-2
Key exclusion criteria
1. severe complication
2. without informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Jingu |
Organization
Tohoku university graduate school of medicine
Division name
Department of Radiuation Oncology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
+81-22-717-7312
kjingu-jr@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Jingu |
Organization
Tohoku university graduate school of medicine
Division name
Department of Radiuation Oncology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
+81-22-717-7312
Homepage URL
kjingu-jr@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
HIROMI Medical Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022172
