UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030385 |
|---|---|
| Receipt number | 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 17:55:26 |
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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
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
shibat03@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034608
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
