UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026898 |
|---|---|
| Receipt number | 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 12:41:27 |
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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
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
ethics@adm.niigata-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030846
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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