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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035351
Receipt No. R000039068
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 -
Date of disclosure of the study information 2020/01/04
Last modified on 2020/09/26

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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 10

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
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
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
2019 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 09 Month 02 Day

Other
Other related information nothing

Management information
Registered date
2018 Year 12 Month 23 Day
Last modified on
2020 Year 09 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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