UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041608