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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030385
Receipt No. R000034608
Scientific Title The efficiency of nanobubble therapy for oral mucositis during chemotherapy for the patients of advanced gastrointestinal cancer
Date of disclosure of the study information 2018/01/08
Last modified on 2019/06/18

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Basic information
Public title The efficiency of nanobubble therapy for oral mucositis during chemotherapy for the patients of advanced gastrointestinal cancer
Acronym nanobubble therapy for oral mucositis
Scientific Title The efficiency of nanobubble therapy for oral mucositis during chemotherapy for the patients of advanced gastrointestinal cancer
Scientific Title:Acronym nanobubble therapy for oral mucositis
Region
Japan

Condition
Condition oral mucositis during chemotherapy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine the efficiency of nanobubble treatment for the oral mucositis in patients under advanced cancer chemoradiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of oral mucositis with grade 2 or more according to CTCAEv 4.0 grade and patient questionnaire
Key secondary outcomes Side effects, The most severe grade of oral mucositis, Period of disappearance of oral mucositis, Adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 administration of nano-bubble water
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
95 years-old >=
Gender Male and Female
Key inclusion criteria Patients who undergo anticancer drugs or radiotherapy for relapsed / advanced cancer
Key exclusion criteria Patients who already have a oral mucositis at the beginning of the study, Patients with underlying diseases associated with oral mucositis such as collagen disease
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Shibata
Organization Fujita Health University Hospital
Division name Gastroenterology
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho 470-1192, Toyoake, Japan
TEL 0562-93-9240
Email shibat03@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Shibata
Organization Fujita Health University Hospital
Division name Gastroenterology
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho 470-1192, Toyoake, Japan
TEL 0562-93-9240
Homepage URL
Email shibat03@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Center for research promotion and support
Address 1-98 Dengakugakubo, Kutsukake-cho 470-1192, Toyoake, Japan
Tel 0562-93-2865
Email f-irb@fujita-hu.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 藤田医科大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 08 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
2018 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2021 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
2017 Year 12 Month 13 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034608

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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