UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013281 |
|---|---|
| Receipt number | R000015461 |
| Scientific Title | Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy. |
| Date of disclosure of the study information | 2014/03/03 |
| Last modified on | 2014/02/26 13:42:31 |
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Basic information
Public title
Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.
Acronym
Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.
Scientific Title
Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.
Scientific Title:Acronym
Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.
Region
| Japan |
Condition
Condition
head and neck cancer, oral cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Oto-rhino-laryngology |
| Radiology | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
"Hange-shashin-to" was widely used in neurological gastritis, nausea and dyspepsia. This medicine have a indication for oral mucositis because of these anti-inflammatory effect when we take it for internal use. Preventive effect of gargling "Hange-shashin-to" for oral mucositis was not verified.
We planned to validate of efficacy of gargling "Hange-shashin-to" about patients who contracted head and neck cancer and oral cancer which are scheduled chemotherapy or chemoradiotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Objective evaluation: CTCAE ver.4.0, food requirement, blood examination(total protein, albumin, inflammatory cytokine, etc)
Subjective assesment: patients questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group: Patients gargles with azulene sodium sulfonate three times a day since treatment start.
Interventions/Control_2
Hange-shashin-to group: Patients gargles with Hange-shashin-to three times a day since treatment start.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients, who suffered from oral cancer or head and neck cancer, planned chemotherapy and chemoradiotherapy.
Key exclusion criteria
The patients uses gargling before treatment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nodoka Sekiguchi |
Organization
Shinshu University
Division name
Department of Comprehensive Cancer Therapy
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-35-4600
nodokas@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nodoka Sekiguchi |
Organization
Shinshu University
Division name
Department of Comprehensive Cancer Therapy
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-35-4600
Homepage URL
nodokas@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu 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
| 2014 | Year | 03 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 03 | 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
| 2014 | Year | 02 | Month | 26 | Day |
Last modified on
| 2014 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015461
