UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022003
Receipt number R000023199
Scientific Title A study on the effect of "Sasahealth" used for oral mucositis associated with the anti-cancer agent administration
Date of disclosure of the study information 2016/04/20
Last modified on 2017/08/30 18:28:05

* 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

A study on the effect of "Sasahealth" used for oral mucositis associated with the anti-cancer agent administration

Acronym

A study on the effect of "Sasahealth" used for oral mucositis associated with the anti-cancer agent administration

Scientific Title

A study on the effect of "Sasahealth" used for oral mucositis associated with the anti-cancer agent administration

Scientific Title:Acronym

A study on the effect of "Sasahealth" used for oral mucositis associated with the anti-cancer agent administration

Region

Japan


Condition

Condition

Oral mucositis which was developed by the side effects of anti-cancer drug therapy for lung cancer

Classification by specialty

Pneumology Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Collecting basic data on the effect of "Sasahealth" for oral mucositis that occurs as an adverse event of the anti-cancer agent administration

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1.The evaluation of oral mucositis after "Sasahealth" p.o.
2.The searching for inflammatory markers (IL-6, IL-8, etc.)in the saliva after "Sasahealth" p.o.

Key secondary outcomes

1.Safety assessment(adverse event)
2.Diary described
3.Questionnaire survey


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sasahealth 6.7mg gargled three times a day for 60 seconds before meals.

Interventions/Control_2

Sasahealth 6.7mg gargled three times a day for 60 seconds before meals.

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

1. Subjects are competent to consent, keep the rules of the study and are able to report self-condition.
2. Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
3. Subjects who developed oral mucositis within one month or during chemotherapy newly.
4. Subjects who performed chemotherapy or planed to at department of Respiratory medicine in our clinic.

Key exclusion criteria

1. Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug poisoning, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc)
2.Any history for drug allergy
3. Subjects within three months after the participation to other clinical trials
4.Subjects who are inadequate for enrollment judged by the investigator.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio HORIE

Organization

Saitama Medical Center
Saitama Medical University

Division name

Department of Oral and MaxillofacialSurgery

Zip code


Address

1981 Kamoda, Kawagoe 350-8550 Saitama

TEL

049-228-3687

Email

horien@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norio HORIE

Organization

Saitama Medical Center Saitama Medical University

Division name

Department of Oral and MaxillofacialSurgery

Zip code


Address

1981 Kamoda, Kawagoe 350-8550 Saitama

TEL

049-228-3687

Homepage URL


Email

horien@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical Center Saitama Medical University. Department of Oral and MaxillofacialSurgery.

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Saitama Medical Center, Saitama Medical University, Department of Respiratory medicine

Saitama Medical Center, Saitama Medical University, Department of chemotherapy

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

埼玉医科大学総合医療センター(埼玉県)


Other administrative information

Date of disclosure of the study information

2016 Year 04 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


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

Open public recruiting

Date of protocol fixation

2015 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 20 Day

Last modified on

2017 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023199


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name