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 | 2025/03/03 13:16:11 |
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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
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
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
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2016 | 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
| 2014 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017397
