UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025937
Receipt number R000029822
Scientific Title The effect of Dried Bonito Broth on the hand-foot syndrome induced by sorafenib administration for hepatocellular carcinoma
Date of disclosure of the study information 2017/01/31
Last modified on 2021/02/03 10:26:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effect of Dried Bonito Broth on the hand-foot syndrome induced by sorafenib administration for hepatocellular carcinoma

Acronym

The effect of an Dried Bonito Broth on the hand-foot syndrome induced by sorafenib administration

Scientific Title

The effect of Dried Bonito Broth on the hand-foot syndrome induced by sorafenib administration for hepatocellular carcinoma

Scientific Title:Acronym

The effect of an Dried Bonito Broth 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 a dried bonito broth 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.


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 a dried bonito broth

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.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kenya
Middle name
Last name Kamimura

Organization

Niigata University

Division name

Division of Gastroenterology and Hepatology

Zip code

9518510

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 Kenya
Middle name
Last name Kamimura

Organization

same as above

Division name

same as above

Zip code

9518510

Address

same as above

TEL

0252272207

Homepage URL


Email

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

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB in Niigata Univ.

Address

1-757, Asahimachido-ri, Chuo-ku, Niigata

Tel

025-227-2625

Email

ethics@adm.niigata-u.ac.jp


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)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/29713197/, https://pubmed.ncbi.nlm.nih.gov/31191006/

Number of participants that the trial has enrolled

43

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

2012 Year 08 Month 30 Day

Date of IRB

2012 Year 08 Month 30 Day

Anticipated trial start date

2012 Year 09 Month 01 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 31 Day

Last modified on

2021 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name