UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030091 |
|---|---|
| Receipt number | R000033903 |
| Scientific Title | Parallel competitive study in two groups to examine the effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy |
| Date of disclosure of the study information | 2017/11/23 |
| Last modified on | 2018/01/04 13:56:23 |
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Basic information
Public title
Parallel competitive study in two groups to examine the effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy
Acronym
Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy
Scientific Title
Parallel competitive study in two groups to examine the effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy
Scientific Title:Acronym
Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy
Region
| Japan |
Condition
Condition
mucositis in patients receiving radiation therapy
Classification by specialty
| Oto-rhino-laryngology | Radiology | Anesthesiology |
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effectiveness of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy for head and neck cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum Grade in severity score for oral mucositis :NCI-CTC/CTCAE V4
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oren-to and standard therapy for oral mucositis
Interventions/Control_2
Standard therapy for oral mucositis only
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
Patients receiving radiation therapy (60Gy) combined with anti-cancer medication (cisplatin) for head and neck cancer (oral, oro- and hypo-pharyngeal cancer)
Key exclusion criteria
1. Patient who cannot take Kampo medications at start of this research
2. Patient with allergy for oren-to
3. Patient who is judged to be inappropriate to carry out the research safely by the principal or sub investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao NAMIKI |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Japanese-Oriental (Kampo) Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba City
TEL
+81-43-226-2984
tnamiki@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao NAMIKI |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Japanese-Oriental (Kampo) Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba City
TEL
+81-43-226-2984
Homepage URL
tnamiki@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Japanese-Oriental (Kampo) Medicine,Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | 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
| 2017 | Year | 11 | Month | 23 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
