UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015106 |
|---|---|
| Receipt number | R000017581 |
| Scientific Title | impact on quality of life by hypo-salivation and dysgeusia caused by chemoradiotherapy for head and neck cancer patient |
| Date of disclosure of the study information | 2014/09/20 |
| Last modified on | 2015/10/16 12:25:42 |
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Basic information
Public title
impact on quality of life by hypo-salivation and dysgeusia caused by chemoradiotherapy for head and neck cancer patient
Acronym
hypo-salivation and dysgeusia caused by chemoradiotherapy
Scientific Title
impact on quality of life by hypo-salivation and dysgeusia caused by chemoradiotherapy for head and neck cancer patient
Scientific Title:Acronym
hypo-salivation and dysgeusia caused by chemoradiotherapy
Region
| Japan |
Condition
Condition
patient with head and neck cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the relationship between hypo-salivation and dysgeusia induced by chemoradiotherapy for head and neck cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of salivation before, during and after chemoradiotherapy
change of tasting before, during and after chemoradiotherapy
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
evaluation of tasting using taste disc (Sanwa Kagaku Kenkyuujyo Co., Ltd. Nagoya, Japan)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
head and neck cancer
no history of cancer treatment
intraoral intake
performance status (ECOG) 0-2
preserved main organs
Key exclusion criteria
no obtaining written informed consent
no plan for chemoradiation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chika Yasuda |
Organization
Kawasaki Medical School Hospital
Division name
Nursing department
Zip code
Address
577 Matsushima Kurashiki-shi Okayama pref., Japan
TEL
+81-86-462-1111
chika.7.yasuda@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chika Yasuda |
Organization
Kawasaki Medical School Hospital
Division name
Nursing department
Zip code
Address
577 Matsuhsima Kurashiki-shi Okayama pref. Japan
TEL
+81-86-462-1111
Homepage URL
chika.7.yasuda@gmail.com
Sponsor or person
Institute
Nursing department of Kawasaki Medical School hospital
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Fundation for Medical Science and Medial Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 09 | Month | 20 | 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
| 2014 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 10 | Day |
Last modified on
| 2015 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017581
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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