UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028552 |
|---|---|
| Receipt number | R000032679 |
| Scientific Title | Safety of laser therapy for oral mucositis due to chemotherapy or moleculary targeted drug therapy. |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/02/16 00:46:29 |
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Basic information
Public title
Safety of laser therapy for oral mucositis due to chemotherapy or moleculary targeted drug therapy.
Acronym
Safety of laser therapy for oral mucositis due to chemotherapy or moleculary targeted drug therapy.
Scientific Title
Safety of laser therapy for oral mucositis due to chemotherapy or moleculary targeted drug therapy.
Scientific Title:Acronym
Safety of laser therapy for oral mucositis due to chemotherapy or moleculary targeted drug therapy.
Region
| Japan |
Condition
Condition
oral mucositis due to chemotherapy or molecularly targeted drug therapy.
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We consider about safety of laser therapy for oral mucositis due to chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in a subjective symptom (VAS), Grade classification of a mouth mucousitis by NCI - CTCAE, the size, a part and contact teeth, the dental hygiene situation and blood exam.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Lasers are applied to a mouth mucousitis directly.
When there is no reduction in symptom, it's repeated by the frequency of the once a week.
Interventions/Control_2
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases with oral mucositis due to chemotherapy or molecular target drug therapy, and which are not over 1/3 whole mouth.
Key exclusion criteria
Less than 20 years old, or the case which a oral mucousitis is Grade 4 or 5 by classification of NCI-CTCAE.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Emiko Isomura |
Organization
Osaka University Hospital
Division name
The Unit of dentisty
Zip code
Address
2-15 Yamadaoka Suita-city, Osaka
TEL
0668795111
tanaemi@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emiko Isomura |
Organization
Osaka University Hospital
Division name
The Unit of dentisty
Zip code
Address
2-15 Yamadaoka Suita-city, Osaka
TEL
0668795111
Homepage URL
tanaemi@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka University Hospital
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
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 | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032679
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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