UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061695 |
|---|---|
| Receipt number | R000070593 |
| Scientific Title | Effect of Ozone Nanobubble Water on Chemotherapy-Induced Oral Mucositis |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/26 15:16:31 |
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Basic information
Public title
Effect of Ozone Nanobubble Water on Chemotherapy-Induced Oral Mucositis
Acronym
Effect of Ozone Nanobubble Water on Chemotherapy-Induced Oral Mucositis
Scientific Title
Effect of Ozone Nanobubble Water on Chemotherapy-Induced Oral Mucositis
Scientific Title:Acronym
Effect of Ozone Nanobubble Water on Chemotherapy-Induced Oral Mucositis
Region
| Japan |
Condition
Condition
colorectal or gastric cancer receiving chemotherapy regimens including FOLFOX or XELOX.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence and severity of chemotherapy-induced oral mucositis and quality of life (QOL) in patients with gastrointestinal cancers undergoing chemotherapy, between those receiving oral rinsing with ozonated nanobubble water and those receiving standard oral care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of oral mucositis after chemotherapy.
Key secondary outcomes
Severity of oral mucositis and time to onset
Quality of life (QOL)
Taste disorder
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
Participants will perform oral rinsing with ozone nano-bubble water three times daily after tooth brushing during the first cycle of chemotherapy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who meet all of the following criteria will be eligible for inclusion:
1.Patients with colorectal or gastric cancer scheduled to receive chemotherapy regimens including FOLFOX or XELOX
2.Patients who are able to safely perform oral rinsing without choking or aspiration
3.Patients aged 20 years or older at the time of informed consent
4.Patients who have provided written informed consent after receiving adequate explanation using an informed consent document
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1.Patients who are unable to safely and appropriately perform oral rinsing due to swallowing disorders, impaired consciousness, or cognitive impairment
2.Patients with a history of hypersensitivity to any component of ozonated nanobubble water
3.Patients judged by the principal investigator to be inappropriate for participation in this study for safety reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Itano |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba
TEL
0476-35-5600
itano@ihwg.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Nishijima |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba
TEL
0476-35-5600
Homepage URL
anishijima@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nanosui Company
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, International University of Health and Welfare
Address
852 Hatakeda, Narita, Chiba
Tel
0476-35-5600
rinri_md@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
| 2026 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | 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
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070593
