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 |
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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
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
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
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
