UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028552
Receipt No. 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

* 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 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
Email 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
Email tanaemi@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032679

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.