UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014953
Receipt number R000017397
Scientific Title The study of protective efficacy to molecular target drug's dermatopathy by specialized amino acid supplement, Abound(TM)
Date of disclosure of the study information 2014/08/27
Last modified on 2018/08/29 19:19:55

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Basic information

Public title

The study of protective efficacy to molecular target drug's dermatopathy by specialized amino acid supplement, Abound(TM)

Acronym

The study of protective efficacy to molecular target drug's dermatopathy by Abound(TM)

Scientific Title

The study of protective efficacy to molecular target drug's dermatopathy by specialized amino acid supplement, Abound(TM)

Scientific Title:Acronym

The study of protective efficacy to molecular target drug's dermatopathy by Abound(TM)

Region

Japan


Condition

Condition

liver cancer, colorectal cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm a suppressant effect by Abound(TM) for the dermatopathy in the patients used molecular target drugs.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Protective efficacy of dermatopathy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Abound(TM)

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

1.Liver cancer treated by sorafenib
1)The patients confirmed by histological or abdominal imaging examination.
2)Child-Pugh grade A
3)without severe renal dysfunction
4)A written agreement is provided.
2.Colorectal cancer treated by regorafenib
1)The patients confirmed by histological or abdominal imaging examination.
2)without severe renal dysfunction
3)A written agreement is provided.
3.Colorectal cancer treated by panitumumab
1)The patients confirmed by histological or abdominal imaging examination.
2)without k-ras or all ras mutant
3)without severe renal dysfunction
4)A written agreement is provided.

Key exclusion criteria

1)Child-Pugh grade B or C
2)Age is less than 20 years old.
3)The patients who judged a doctor to be inappropriate as an object of this study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Naganuma

Organization

Takasaki General Medical Center, National Hospital Organization

Division name

Department of Gastroenterology

Zip code


Address

36 Takamatsu-machi, Takasaki-city, Gunma

TEL

027-322-5901

Email

numackey@pa2.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Naganuma

Organization

Takasaki General Medical Center, National Hospital Organization

Division name

Department of Gastroenterology

Zip code


Address

36 Takamatsu-machi, Takasaki-city, Gunma

TEL

027-322-5901

Homepage URL


Email

numackey@pa2.so-net.ne.jp


Sponsor or person

Institute

Takasaki General Medical Center, National Hospital Organization

Institute

Department

Personal name



Funding Source

Organization

Takasaki General Medical Center, National Hospital Organization

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 27 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

Open public recruiting

Date of protocol fixation

2014 Year 08 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 27 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

2014 Year 08 Month 26 Day

Last modified on

2018 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017397


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name