UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063513 |
|---|---|
| Receipt number | R000071912 |
| Scientific Title | Effect of a Hinokitiol-Containing Oral Care Gel on Perioperative Oral Bacterial Counts in Patients with Esophageal Cancer: Single-center Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/11/10 |
| Last modified on | 2026/11/04 09:42:01 |
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Basic information
Public title
Effect of a Hinokitiol-Containing Oral Care Gel on Perioperative Oral Bacterial Counts in Patients with Esophageal Cancer: A Prospective Interventional Study
Acronym
Research of oral care for Esophageal cancer
Scientific Title
Effect of a Hinokitiol-Containing Oral Care Gel on Perioperative Oral Bacterial Counts in Patients with Esophageal Cancer: Single-center Randomized Controlled Trial
Scientific Title:Acronym
Effect of oral care for Esophageal cancer: Single-center Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a hinokitiol-containing oral care gel used as part of perioperative oral function management in patients with esophageal cancer on changes in oral bacterial counts, the incidence of chemotherapy-related oral complications, and the incidence of postoperative pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in oral bacterial count
Key secondary outcomes
1. Oral health status assessed using the Oral Assessment Guide (OAG)
2. Incidence of postoperative pneumonia
3. Incidence of chemotherapy-induced oral mucositis
4. Oral dryness assessed using an oral moisture meter
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
An oral care gel containing hinokitiol will be used during perioperative oral function management.
Interventions/Control_2
An oral care gel containing hinokitiol will not be used during perioperative oral function management, and the oral care products routinely used at the study site will be used instead.
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
Patients who meet all of the following criteria:
1. Age >=20 years, regardless of sex.
2. Histologically and/or cytologically confirmed esophageal cancer.
3. Clinical stage (cStage) 0-IV.
4. ECOG Performance Status of 0-2.
5. Ability to attend outpatient visits for at least 90 days after hospital discharge.
6. Provision of voluntary written informed consent after receiving a sufficient explanation of the study and fully understanding its contents.
Key exclusion criteria
Patients who meet any of the following criteria:
1. Eligible for endoscopic treatment, or having undergone endoscopic treatment without the need for additional treatment.
2. Presence of multiple primary cancers.
3. Poorly controlled diabetes mellitus (HbA1c >=8.4%).
4. Severe hepatic impairment, renal impairment, or cardiovascular disease, as assessed with reference to Grade 3 of the JCOG version of CTCAE v5.0.
5. Severe oral conditions that may affect the oral bacterial count, such as oral mucositis or severe dry mouth, as assessed with reference to Grade 3 of the JCOG version of CTCAE v5.0.
6. Considered unsuitable for participation in the study by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ueno |
Organization
Toranomon Hospital
Division name
Department of Gastroenterological Surgery
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
ueno@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Shimoyama |
Organization
Toranomon Hospital
Division name
Department of Gastroenterological Surgery
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
hayatos@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Hayato Shimoyama
Funding Source
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital
Address
2-2-2 Toranomon, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim2@toranomon.gr.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 | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071912
