UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of pilocarpine for xerostomia induced by radiation therapy at different administration timing.
Title of the study (Brief title)	The efficacy of pilocarpine for xerostomia induced by radiation therapy at different administration timing.
Region	Japan

Condition
Condition	xerostomia
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of pilocarpine for xerostomia at different administration timing, during and after radiation therapy for head and neck cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a visual analog scale xerostomia questionnaire quantity of secreted saliva
Key secondary outcomes	Oral findings

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	To compare the efficacy of pilocarpine for xerostomia at different administration timing, during and after radiation therapy for head and neck cancer patients.
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 received radiation therapy for epipharynx, oropharynx and pharynx. 2. Written informed consent obtained before begingingany investigational procedures.
Key exclusion criteria	1. Patients who have contraindication to pilocarpine. 2. Pregnant women or patients who have possibility of pregnancy. 3. Patients the principal investigator deems unsuitable as a subject.
Target sample size	20

Research contact person
Name of lead principal investigator	Masako Uno
Organization	Kawasaki Medical School
Division name	Otorhinolaryngology
Address	577 Matsushima, Kurashiki, Okayama 701-019
TEL	086-462-1111
Email	unomako@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Mariko Moriya
Organization	Kawasaki Medical School
Division name	Otorhinolaryngology
Address	unomako@med.kawasaki-m.ac.jp
TEL	086-462-1111
Homepage URL
Email	moriya@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Otorhinolaryngology, Kawasaki Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	川崎医科大学

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 21 Day
Last modified on	2018 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012047