UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030489
Receipt number R000034602
Scientific Title Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.
Date of disclosure of the study information 2017/12/20
Last modified on 2022/02/03 16:38:51

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Basic information

Public title

Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.

Acronym

Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.

Scientific Title

Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.

Scientific Title:Acronym

Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

prevention of chemotherapy-induced stomatitis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of stomatitis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

dexamethasone mouthwash

Interventions/Control_2

control

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

Female

Key inclusion criteria

1. Patients with invasive breast cancer
2. Planned regimen is EC or TC
3. No previous chemotherapy
4. Patients without stomatitis at recruit
5. Without of inadequate dentures
6. Patients that PS is 0-1

Key exclusion criteria

1. Advanced breast cancer patients
2. Patients with pregnant

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Susumu
Middle name
Last name Eguchi

Organization

Nagasaki University Graduate School of Biomedical Science

Division name

Surgery

Zip code

852-8501

Address

1-17-1, Sakamoto-machi

TEL

095-849-7316

Email

sueguchi@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Sayaka
Middle name
Last name Kuba

Organization

Nagasaki University Graduate School of Biomedical Science

Division name

Surgery

Zip code

852-8501

Address

1-7-1, Sakamoto-machi, Nagasaki city

TEL

095-849-7316

Homepage URL


Email

skuba@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Graduate School of Biomedical Science

Institute

Department

Personal name



Funding Source

Organization

Japan Cancer Society

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital Clinical Research Ethical Committee

Address

1-7-1, Sakamoto-machi, Nagasaki city

Tel

0958197726

Email

rinshou7726@umin.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

2017 Year 12 Month 20 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

121

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

Completed

Date of protocol fixation

2017 Year 12 Month 06 Day

Date of IRB

2017 Year 12 Month 18 Day

Anticipated trial start date

2018 Year 01 Month 04 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2021 Year 12 Month 20 Day

Date analysis concluded

2022 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 20 Day

Last modified on

2022 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034602


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/06/15 DATA sharing 1.xlsx