UMIN-ICDS Clinical Trial

Public title

Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy: A prospective study

Acronym

Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy

Scientific Title

Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy: A prospective study

Scientific Title:Acronym

Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy

Region

Japan

Condition

Head and neck cancer patients

Classification by specialty

Oto-rhino-laryngology	Radiology	Oral surgery
Dental medicine

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

The purpose of this study is to observe the change in oral bacterial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the onset of radiation induced mucositis.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study is to observe the change in oral bacterial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the onset of radiation induced mucositis.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To observe the change in oral bacterial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the onset of radiation induced mucositis.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) A Malignant tumor in the head and neck region.
(2) The lesion is measurable.
3) Radiotherapy is planned.
4) The oral mucosa may be irradiated.
5) The patient is over 18 years of age.
6) Performance Status (PS) is 0-2.
(7) The patient has been informed of the name and condition of the disease and is capable of consenting.

Key exclusion criteria

1) Previous radiation therapy to the area to be treated.
2) Active and refractory infection at the irradiated site.
(3) Severe complications (uncontrolled diabetes, myocardial infarction, unstable angina, uncontrolled arrhythmia, bleeding tendency, collagen disease requiring steroid administration, etc.).
(4) Active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free interval of 5 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in the active overlapping cancers.
(5) Previous surgery in the radiotherapy area.
(6) An event occurs during the study period for which radiotherapy should not be initiated.
(7) The patient is found not to have a malignant tumor in the head and neck region after the start of the study.
(8) If it becomes difficult to continue radiotherapy for some reason after the start of the study.
(9) Other medical, psychological, or other factors that make the physician in charge of the patient inappropriate for the study.

Target sample size

66

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Ohno

Organization

Gunma University Graduate School of Medicine.

Division name

Department of Radiation Oncology

Zip code

3718511

Address

3-39-22 Showa-machi, Maebashi, Gunma

TEL

027-220-8383

Email

tohno@gunma-u.ac.jp

Name of contact person

1st name	Atsushi
Middle name
Last name	Musha

Organization

Gunma University

Division name

Heavy Ion Medical Center

Zip code

3718511

Address

3-39-22 Showa-machi, Maebashi, Gunma

TEL

027-220-8378

Homepage URL

Email

musha@gunma-u.ac.jp

Institute

Gunma University

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Gunma University Hospital Clinical Research Review Board

Address

3-39-15 Showa-machi, Maebashi, Gunma

Tel

027-220-8740

Email

gunmaciru-office@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

03

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

03

Month

09

Day

Date of IRB

2023

Year

03

Month

20

Day

Anticipated trial start date

2023

Year

04

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To be registered after analysis is completed.

Registered date

2023

Year

03

Month

22

Day

Last modified on

2023

Year

03

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057360