UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036529 |
|---|---|
| Receipt number | R000041608 |
| Scientific Title | Clinical research on the efficacy of pilocarpine hydrochloride administration from the early stage of treatment for the reduction of oral mucositis in oral cancer radiation therapy. |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2020/04/17 19:06:17 |
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Basic information
Public title
Clinical research on the efficacy of pilocarpine hydrochloride administration from the early stage of treatment for the reduction of oral mucositis in oral cancer radiation therapy.
Acronym
Clinical research on the efficacy of pilocarpine hydrochloride administration.
Scientific Title
Clinical research on the efficacy of pilocarpine hydrochloride administration from the early stage of treatment for the reduction of oral mucositis in oral cancer radiation therapy.
Scientific Title:Acronym
Clinical research on the efficacy of pilocarpine hydrochloride administration.
Region
| Japan |
Condition
Condition
oral mucositis in oral cancer radiation therapy
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
reduction of oral mucositis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Period of oral intake
Key secondary outcomes
Severity of oral mucositis, and amount of saliva secretion at rest
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of pilocarpine hydrochloride.
A dose of 5mg will be taken orally after meals three times a day, and the administration period will be 12 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who undergo SSIACRT for oral cancer.
2)Patients with no history of radiation exposure to the head and neck.
3)Patients who have not had surgery for salivary gland disease in the past.
4)Patients who do not notice symptoms of xerostomia prior to SSIACRT.
Key exclusion criteria
1)Patients who fall under contraindications in the package insert.
2)Patients taking medications with interaction.
3)Patients judged to be inappropriate by their doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanaka |
Organization
Hirosaki University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
036-8563
Address
3, Hon-cho, Hirosaki City, Aomori Prefecture, Japan.
TEL
0172-39-5127
tanayuu820@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanaka |
Organization
Hirosaki University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
036-8563
Address
53, Hon-cho, Hirosaki City, Aomori Prefecture, Japan.
TEL
0172-39-5127
Homepage URL
tanayuu820@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
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
Hirosaki University Certified Review Board
Address
53, Hon-cho, Hirosaki City, Aomori Prefecture, Japan.
Tel
0172-39-5295
cksenta@cc.hirosaki-u.ac.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
弘前大学医学部附属病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 04 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041608
