UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034332 |
|---|---|
| Receipt number | R000038691 |
| Scientific Title | Change in the taste with the cancer chemotherapy and effort to zinc supplement |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/10/01 10:16:04 |
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Basic information
Public title
Change in the taste with the cancer chemotherapy and effort to zinc supplement
Acronym
Chemotherapy and zinc supplement
Scientific Title
Change in the taste with the cancer chemotherapy and effort to zinc supplement
Scientific Title:Acronym
Chemotherapy and zinc supplement
Region
| Japan |
Condition
Condition
Clinical oncology
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The taste obstacle could improve by doing zinc supplement in cancer chemotherapy.
Basic objectives2
Others
Basic objectives -Others
A rise of the serum zinc value followed by zinc supplement in cancer chemotherapy could improve the taste obstacle. Correlation between zinc and the taste is considered.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in the taste by the taste disk after 3 months chemotherapy and correlation with zinc supplement is considered.
Key secondary outcomes
Correlation between the zinc intake and the serum zinc value is considered
Correlation between the taste obstacle and the serum zinc value is considered.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
You take the dietary supplement which has strengthened the zinc (Arginaid Water), the taste ckeck using the taste disk and several nutritional index including the serum zinc value is examined in before and 3 months later of chemotherapy introduction.
You take a dietary supplement after chemotherapy introduction and wish for the amount desires, and the maximum amount is set to 12. The person who doesn't wish makes a dietary supplement the subject, too.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who newly introduces cancer chemotherapy by the surgery of Uwajima city hospital is subjected.
Key exclusion criteria
Patient with the taste obstacle
Patient with cognitive disfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Okada |
Organization
Uwajima City Hospital
Division name
Department of Surgery
Zip code
798-8511
Address
1-1 Goten-machi, Uwajima city, Ehime prefecture
TEL
0895-25-1111
okada@uwajima-mh.jp
Public contact
Name of contact person
| 1st name | Kenzo |
| Middle name | |
| Last name | Okada |
Organization
Uwajima City Hospital
Division name
Department of Surgery
Zip code
798-8511
Address
1-1 Goten-machi, Uwajima city, Ehime prefecture
TEL
0895-25-1111
Homepage URL
http://www.uwajima-mh.jp
okada@uwajima-mh.jp
Sponsor or person
Institute
Uwajima City Hospital
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Uwajima City Hospital
Department of Surgery
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Uwajima City Hospital
Address
1-1 Goten-machi, Uwajima city, Ehime prefecture
Tel
0895-25-1111
0895-25-5334
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
市立宇和島病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038691
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
