UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of oral health care for perioperative thoracic esophageal cancer -prospective non-randomized trial
Acronym	Trial for usefulness of oral care in thoracic esophageal cancer
Scientific Title	Usefulness of oral health care for perioperative thoracic esophageal cancer -prospective non-randomized trial
Scientific Title:Acronym	Trial for usefulness of oral care in thoracic esophageal cancer
Region	Japan

Condition
Condition	Thoracic esophageal cancer
Classification by specialty	Gastrointestinal surgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To estimate efficacy of oral health care in perioperative thoracic esophageal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate acetaldehyde production from oral microbiota.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	oral health care for perioperative thoracic esophageal cancer
Interventions/Control_2	oral health care for healthy controls
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) Thoracic esophageal cancer (2) Clinical stage (T1aN1M0, T1bN0M0) (T1aN2M0, T1bN1M0, T1bN2M0,T2N0M0, T2N1M0, T3N0M0) (T3N1M0, T3N2M0, T3N3M0, T4N0M0) (3) ECOG Performance Status Scale:0,1 (4) Age: 20-80 years old (5) Signed informed consent
Key exclusion criteria	(1) Active concomitant malignancy (2) Adults without sufficient judgement capacity (3) Other conditions judged ineligible by physician
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoko Tanda
Organization	Tohoku University Hospital
Division name	Department of Preventive Dentistry
Zip code
Address	Seiryo-machi 1-1, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-8330
Email	ntanda@m.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naoko Tanda
Organization	Tohoku University Graduate School of Dentistry
Division name	Division of Preventive Dentistry
Zip code
Address	Seiryo-machi 4-1, Aoba-ku, Sendai, 980-8575, Japan
TEL	022-717-8328
Homepage URL
Email	ntanda@m.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 12 Month 24 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	Main results already published
Date of protocol fixation	2015 Year 11 Month 20 Day
Date of IRB	2015 Year 11 Month 20 Day
Anticipated trial start date	2015 Year 12 Month 25 Day
Last follow-up date	2018 Year 02 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We observe acetaldehyde production from oral microbiota, acetaldehyde from mouth air and breath, and number of oral microbiota in saliva before and after oral care. We also examine Genotype of ADH1B and ALDH2. Twenty patients and 20 healthy subjects as control are observed.

Management information
Registered date	2015 Year 12 Month 16 Day
Last modified on	2019 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023333