UMIN-CTR Clinical Trial

Basic information
Public title	On the relationship between the amount of physical activity during preoperative chemotherapy and the Muscle Loss Index in patients with esophageal cancer - Pilot study for multi - occupational collaborative intervention -
Acronym	Study of esophageal cancer patients
Scientific Title	On the relationship between the amount of physical activity during preoperative chemotherapy and the Muscle Loss Index in patients with esophageal cancer - Pilot study for multi - occupational collaborative intervention -
Scientific Title:Acronym	Study of esophageal cancer patients
Region	Japan

Condition
Condition	Esophagus cancer
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verify the relationship between physical activity level and skeletal muscle atrophy of esophageal cancer patients during chemotherapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skeletal muscle mass
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	65 years-old <=
Age-upper limit	100 years-old >
Gender	Male
Key inclusion criteria	1.aged at the time of obtaining 65 years or older 2.gender: male 3.stage: stage2-4 (esophageal cancer handling regulation 11th edition) 4.plan to implement DCF 2 courses as NAC 5.agree to participate in research by free will Can be obtained from the person himself / herself 6.I understand the clinical significance of this research and its importance
Key exclusion criteria	1.not having sarcopenia at recruitment based on criteria advocated by EWGSOP (European Working Group on Sarcopeneia in Older People) and Cut-off value of JSH (Japan Society of Hepatology) SARCOPENIA and diagnosis 3 1.SMI: 7.0 ( Less than 2 kg) 3. Grip strength: less than 26 (kg) 3. Walking speed: 0.8 (m / sec) or less 2) Effect on outcome such as cognitive dysfunction, cerebrovascular disorder, orthopedic disease, peripheral vascular disorder 3.It has electronic devices such as pacemakers whose measurement of Inbody is contraindicated 4.Has a gastrostomy due to eating difficulties
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Ikeda
Organization	OKAYAMA UNIVERSITY HOSPITAL
Division name	General rehabilitation department
Zip code	7008558
Address	700-8558,Okayamashi,kitaku,ksikatacho,2-5-1
TEL	0862357752
Email	lirfranjitte@yahoo.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Ikeda
Organization	OKAYAMA UNIVERSITY HOSPITAL
Division name	General rehabilitation department
Zip code	7008558
Address	700-8558,Okayamashi,kitaku,sikatacho,2-5-1
TEL	086-235-7752
Homepage URL
Email	lirfranjitte@yahoo.co.jp

Sponsor
Institute	OKAYAMA UNIVERSITY HOSPITAL
Institute
Department

Funding Source
Organization	nothing
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	OKAYAMA UNIVERSITY HOSPITAL
Address	Okayamashi,kitaku,sikatacho,2-5-1
Tel	0862357752
Email	lirfranjitte@yahoo.co.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	2020 Year 01 Month 04 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	10
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Due to the spread of COVID-19 infection
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	2018 Year 07 Month 04 Day
Date of IRB	2018 Year 11 Month 01 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 10 Day

Other
Other related information	nothing

Management information
Registered date	2018 Year 12 Month 23 Day
Last modified on	2022 Year 06 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039068