UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038361
Receipt number R000043718
Scientific Title Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Date of disclosure of the study information 2020/04/01
Last modified on 2023/11/01 17:37:56

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients

Acronym

Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients

Scientific Title

Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients

Scientific Title:Acronym

Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastrointestinal surgery Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between gum chewing training during perioperative period and tongue pressure after surgery in the patients with esophageal cancer surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The ratio of the patients whose tongue pressure was decreased the day after 2 weeks of surgery

Key secondary outcomes

The following data will be evaluated on 1) The starting day of gum chewing, 2) The day before surgery, 3) The day after 2 weeks of surgery.
-Swallowing function: tongue pressure, RSST, presence/absence of recurrent laryngeal nerve palsy, oral diadocokinesis
-Masticatory function: Masticatory ability, occlusal force
-Oral hygiene: degree of tongue coating, total number of bacteria on back of tongue, bacterial flora
-Mouth dryness: Oral moisture meter measurement value
-Equilibrium function: Opening one leg up time

The following data will be evaluated on the period between the starting day of gum chewing and the day of end of observational period
-Adverse events, safety: Postoperative complications such as suture failure, accidents due to gum mastication (detachment of prostheses and restorations, temporomandibular joint pain, etc.), and other adverse events
-Postoperative lung complications (JCOG postoperative complication criteria (Clavien-Dindo classification)) v2.0
-Nutrition related items: Oral intake start time, discharge time, ratio of oral intake to total nutrition intake, ratio of home discharge and hospital transfer, etc.
-Postoperative delirium: Contents of medical records


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Gum chewing training during perioperative period in the patients with esophageal cancer

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

The patients who undergo thoracic esophageal cancer surgery at our hospital
1) The patients who will undergo primary radical operation
2) The Patients who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding

Key exclusion criteria

1)The patients who cannot gum chewing because of denture or something
2) The Patients who are determined to be inappropriate as research subjects by the principal investigator or other investigators

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Reiko
Middle name Yamanaka
Last name Kohno

Organization

Okayama University Hospital

Division name

Hospital Dentistry

Zip code

7008558

Address

2-5-1, Shikata-cho, Kita-ku, Okayama

TEL

81862356588

Email

reiko_y@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name Reiko
Middle name
Last name Yamanaka

Organization

Okayama University hospital

Division name

Hospital Dentistry

Zip code

7008558

Address

2-5-1, Shikata-cho, Kita-ku, Okayama

TEL

81862356588

Homepage URL


Email

reiko_y@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name

Reiko Yamanaka


Funding Source

Organization

the Japan Society for the Promotion of Science (JSPS)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

8020 Promotion Foundation


IRB Contact (For public release)

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1, Shikata-cho, kita-ku, Okayama, 7008558

Tel

086-235-6503, 6938

Email

mae6605@adm.okayama-u.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

岡山大学病院


Other administrative information

Date of disclosure of the study information

2020 Year 04 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

40

Results

Thirty-two patients of all of 40 patients completed perioperative gum chewing training. After the propensity score matching, a matched cohort of 25 pairs of cases was created in Gum Chewing, and Historical Control Group). Eleven patients (44.0%) in Gum Chewing Group was decreased on tongue pressure 2 weeks postoperatively, and significantly fewer than 19 patients (76.0%) in Historical Control Group (95% CI, 0.07 - 0.83, p = 0.02).

Results date posted

2023 Year 11 Month 01 Day

Results Delayed

Delay expected

Results Delay Reason

Because the paper has not been completed yet.

Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

nothing special

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 10 Month 23 Day

Date of IRB

2020 Year 09 Month 29 Day

Anticipated trial start date

2021 Year 03 Month 29 Day

Last follow-up date

2022 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

2019 Year 10 Month 22 Day

Last modified on

2023 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name