UMIN-CTR Clinical Trial

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
Email	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
Email	m03039ys@yahoo.co.jp

Sponsor
Institute	Gifu University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050782