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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036529
Receipt No. 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 2019/04/16

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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
Email 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
Email tanayuu820@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2021 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
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041608

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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