UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048273 |
|---|---|
| Receipt number | R000050782 |
| Scientific Title | Relationship between skeletal muscle and amino acid blood levels and adverse events of anticancer drugs |
| Date of disclosure of the study information | 2022/07/05 |
| Last modified on | 2022/07/05 11:13:44 |
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Basic information
Public title
Study on the effect of skeletal muscle mass against side effects and hematological toxicity of chemotherapy
Acronym
Relationship between skeletal muscle mass and anticancer drugs
Scientific Title
Relationship between skeletal muscle and amino acid blood levels and adverse events of anticancer drugs
Scientific Title:Acronym
Searching for the optimal dose of anticancer drug
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Frequency of hematological toxicity, degree of hematological toxicity, transition of iliopsoas muscle area
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of hematological toxicity, degree of hematological toxicity, transition of iliopsoas muscle area, blood amino acid concentration, neutrophil elastase concentration, etc.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
71days
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients undergoing chemotherapy for esophageal cancer within the study period in gastrointestinal surgery. Regardless of age, gender, height or weight.
Key exclusion criteria
No particular exclusion criteria are set. Patients who are judged to be maladaptated by the judgment of physitian.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoshida |
Organization
Gifu University, School of Medicine
Division name
,Department of gastroenterological surgery and pediatric surgery
Zip code
501-0014
Address
1-1 Yanagido Gifu City
TEL
058-230-6235
tana4416@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Sato |
Organization
Gifu University, School of Medicine
Division name
Department of gastroenterological surgery and pediatric surgery
Zip code
501-0014
Address
1-1 Yanagido Gifu City
TEL
058-230-6235
Homepage URL
m03039ys@yahoo.co.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
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
Gifu University Ethics Review Committee
Address
1-1 Yanagido Gifu City
Tel
0582306000
rinri@gifu-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 05 | 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
50
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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not avaiable
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050782
