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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026898
Receipt No. R000030846
Scientific Title The effect of an amino acid on the hand-foot syndrome induced by sorafenib administration for hepatocellular carcinoma
Date of disclosure of the study information 2017/04/20
Last modified on 2018/08/22

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Basic information
Public title The effect of an amino acid on the hand-foot syndrome induced by sorafenib administration for hepatocellular carcinoma
Acronym The effect of an amino acid on the hand-foot syndrome induced by sorafenib administration
Scientific Title The effect of an amino acid on the hand-foot syndrome induced by sorafenib administration for hepatocellular carcinoma
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenya Kamimura
Organization Niigata University
Division name Division of Gastroenterology and Hepatology
Zip code
Address 1-757, Asahimachido-ri, Chuo-ku, Niigata
TEL 0252272207
Email ethics@adm.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name same as above
Organization same as above
Division name same as above
Zip code
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)

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 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

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
2017 Year 03 Month 29 Day
Date of IRB
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

Other
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

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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