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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034332
Receipt No. 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 2018/09/30

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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
Middle name
Last name Kenzo Okada
Organization Uwajima City Hospital
Division name Department of Surgery
Zip code
Address 1-1 Goten-machi, Uwajima city, Ehime prefecture
TEL 0895-25-1111
Email okada@uwajima-mh.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenzo Okada
Organization Uwajima City Hospital
Division name Department of Surgery
Zip code
Address 1-1 Goten-machi, Uwajima city, Ehime prefecture
TEL 0895-25-1111
Homepage URL http://www.uwajima-mh.jp
Email okada@uwajima-mh.jp

Sponsor
Institute Uwajima City Hospital
Department of Surgery
Institute
Department

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
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 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
2018 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038691

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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