UMIN-CTR Clinical Trial

Basic information
Public title	Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Acronym	Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Scientific Title	Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Scientific Title:Acronym	Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of all grade oral mucositis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	oral cryotherapy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The patients who had a diagnosis of invasive breast cancer by needle biopsy or tissue biopsy 2. FEC(EC)100/TC therapy enforcement planned patients 3. The patients who do not receive previous treatment for breast cancer 4. The patients who do not have oral mucositis before treatment 5. The patients without inadequate dentures 6. The patients that PS is 0-1 7. Age is women 80 years or younger 20 years old or older at the time of the agreement acquisition 8. The patients having more than 55% of left ventricular ejection fractions (LVEF) in an echocardiography 9. The patients without the abnormality clinical in an electrocardiogram 10. The patients that an agreement was obtained in a document
Key exclusion criteria	1. Advanced or metastatic breast cancer 2. A pregnant woman and the patients who may be pregnant or the patients whom we are nursing 3. The patients whom a study person in charge judged to be inadequate as study patients
Target sample size	58

Research contact person
Last name of lead principal investigator	1st name Eguchi Middle name Last name Susumu
Organization	Nagasaki University Graduate School of Biomedical Science
Division name	Surgery
Zip code	852-8501
Address	1-17-1, Sakamoto-machi
TEL	095-849-7316
Email	sueguchi@nagasaki-u.ac.jp

Public contact
1st name of contact person	1st name Kuba Middle name Last name Sayaka
Organization	Nagasaki University Graduate School of Biomedical Science
Division name	Surgery
Zip code	852-8501
Address	1-7-1, Sakamoto-machi, Nagasaki city
TEL	095-849-7316
Homepage URL
Email	skuba@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Graduate School of Biomedical Science
Institute
Department

Funding Source
Organization	Nagasaki University Graduate School of Biomedical Science
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	IRB
Address	Sakamoto-machi
Tel	095-819-7726
Email	no

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	2016 Year 06 Month 10 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	Terminated
Date of protocol fixation	2015 Year 12 Month 01 Day
Date of IRB	2016 Year 03 Month 20 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2018 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 02 Day
Last modified on	2019 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025854