UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomize controlled trial on the efficacy of the cryotherapy for dysgeusia with docetaxel.
Title of the study (Brief title)	A randomize controlled trial on the efficacy of the cryotherapy for dysgeusia with docetaxel.
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	No research report on cryotherapy against dysgeusia by docetaxel has been reported so far. Therefore, we aimed to compare two groups of preventive effects by cryotherapy against dysgeusia by docetaxel therapy of breast cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of dysgeusia from docetaxel administration to the next dose.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Include an ice cube into mouth in docetaxel administration as much as possible for (approximately 1 hour).
Interventions/Control_2	No treatment.
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	Female
Key inclusion criteria	Patients who receive docetaxel therapy preoperatively or postoperatively in breast cancer patients over 20 years of age.
Key exclusion criteria	Patients using polaprezink granules or azulene gargle.
Target sample size	40

Research contact person
Name of lead principal investigator	Shigeru Ohmori
Organization	Shinshu University Hospital
Division name	Department of Pharmacy
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-35-4600
Email	somori@shinshu-u.ac.jp

Public contact
Name of contact person	Takayuki Ide
Organization	Shinshu University Hospital
Division name	Department of Pharmacy
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-35-4600
Homepage URL
Email	tkyk@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Government offices of other countries
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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 04 Month 28 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031119