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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022003
Receipt No. 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

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

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
URL(English) https://upload.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


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