UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047116 |
|---|---|
| Receipt number | R000053738 |
| Scientific Title | Effect of hangeshashinto solution on oral mucositis associated with cancer therapy |
| Date of disclosure of the study information | 2022/03/14 |
| Last modified on | 2022/03/08 18:26:26 |
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Basic information
Public title
A Study of gargle for oral mucositis associated with cancer therapy
Acronym
A Study of gargle for oral mucositis associated with cancer therapy
Scientific Title
Effect of hangeshashinto solution on oral mucositis associated with cancer therapy
Scientific Title:Acronym
Effect of hangeshashinto solution on oral mucositis associated with cancer therapy
Region
| Japan |
Condition
Condition
Malignant growth
Classification by specialty
| Endocrine surgery | Breast surgery | Oto-rhino-laryngology |
| Urology | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of hangeshashinto solution on oral mucositis associated with cancer therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Common Terminology Criteria for Adverse Events v3.0
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with oral mucositis during cancer therapy at Nagasaki University Hospital
Key exclusion criteria
Patients with severe hepatic and renal dysfunction
Patients with aldosteronism, myopathy, and hypokalemia
Patients with allergies or other drug sensitivities
pregnant women and patients who may be pregnant or nursing.
Patients who have participated in other clinical studies within 4 months
Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Yamashita |
Organization
Nagasaki University
Division name
Department of Forensic Dental Science, Unit of Social Medicine
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki 852-8102 Japan
TEL
095-819-7076
hiyamashita@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Yamashita |
Organization
Nagasaki University
Division name
Department of Forensic Dental Science, Unit of Social Medicine
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki 852-8102 Japan
TEL
095-819-7076
Homepage URL
hiyamashita@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical Research Center, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501 Japan
Tel
095-819-7726
gaibushikin@ml.nagasaki-u.ac.jp
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
| 2022 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
http://www.mh.nagasaki-u.ac.jp/research/rinsho/patients/data/ended2016-2018.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://search.jamas.or.jp/index.php
Number of participants that the trial has enrolled
10
Results
J. Jpn. Oral Medicine, 22(2), 156-157, 2016
Results date posted
| 2022 | Year | 03 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with oral mucositis during cancer therapy
Participant flow
10 adult men and women who developed oral mucositis during cancer therapy and consented to this study
Adverse events
None
Outcome measures
Common Terminology Criteria for Adverse Events v3.0
Treatment Completion Rate
Body Weight
Serum total Protein
Serum albumin
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Ethics Committee approved the study as a retrospective study.
Management information
Registered date
| 2022 | Year | 03 | Month | 08 | Day |
Last modified on
| 2022 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053738
