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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027177
Receipt No. R000031119
Scientific Title A randomize controlled trial on the efficacy of the cryotherapy for dysgeusia with docetaxel.
Date of disclosure of the study information 2017/05/01
Last modified on 2017/04/27

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Basic information
Public title A randomize controlled trial on the efficacy of the cryotherapy for dysgeusia with docetaxel.
Acronym A randomize controlled trial on the efficacy of the cryotherapy for dysgeusia with docetaxel.
Scientific Title A randomize controlled trial on the efficacy of the cryotherapy for dysgeusia with docetaxel.
Scientific Title:Acronym 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
1st name
Middle name
Last name Shigeru Ohmori
Organization Shinshu University Hospital
Division name Department of Pharmacy
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-35-4600
Email somori@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Ide
Organization Shinshu University Hospital
Division name Department of Pharmacy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 03 Month 06 Day
Date of IRB
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

Other
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

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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