UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of an amino acid on the hand-foot syndrome induced by sorafenib administration for hepatocellular carcinoma
Title of the study (Brief title)	The effect of an amino acid on the hand-foot syndrome induced by sorafenib administration
Region	Japan

Condition
Condition	Hand-foot syndrome
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of an amino acid uptake for the hand-foot syndrome caused by sorafenib administration.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Occurrence of Hand-foot syndrome
Key secondary outcomes	Blood flow in the hands and feet. Changes in appetite, sleep and fatigue obtained by interviews.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Uptake of an amino acid supplement
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients planned to be hospitalized for sorafenib administration for HCC. Patients equal or over 20 years old.
Key exclusion criteria	Patients who has food allergy to fish. Patients who cannot eat and drink by themselves. Patients who have been taking dried-bonito broth to alleviate adverse effects caused by sorafenib.
Target sample size	8

Research contact person
Name of lead principal investigator	Kenya Kamimura
Organization	Niigata University
Division name	Division of Gastroenterology and Hepatology
Address	1-757, Asahimachido-ri, Chuo-ku, Niigata
TEL	0252272207
Email	ethics@adm.niigata-u.ac.jp

Public contact
Name of contact person	same as above
Organization	same as above
Division name	same as above
Address	same as above
TEL	0252272207
Homepage URL
Email	ethics@adm.niigata-u.ac.jp

Sponsor
Institute	Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department

Funding Source
Organization	Ajinomoto, Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	新潟大学医歯学総合病院（新潟県） Niigata University Medical and Dental Hospital

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 29 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 07 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030846