UMIN-CTR Clinical Trial

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
Email	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
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	Uwajima City Hospital
Address	1-1 Goten-machi, Uwajima city, Ehime prefecture
Tel	0895-25-1111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038691