UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory prospective study on the relationship between postoperative sarcopenia and physical activity in patients with esophageal carcinoma
Acronym	Exploratory prospective study on the relationship between postoperative sarcopenia and physical activity in patients with esophageal carcinoma
Scientific Title	Exploratory prospective study on the relationship between postoperative sarcopenia and physical activity in patients with esophageal carcinoma
Scientific Title:Acronym	Exploratory prospective study on the relationship between postoperative sarcopenia and physical activity in patients with esophageal carcinoma
Region	Japan

Condition
Condition	Esophageal carcinoma
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1) To grasp the physical activities before and after treatment of esophageal carcinoma, by measuring metabolic equivalents (METs) by using activity monitor. 2) To evaluate the secondary items related to sarcopenia after esophageal carcinoma surgery.
Basic objectives2	Others
Basic objectives -Others	evaluation of relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Metabolic equivalents (METs)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Surgical cases involving esophageal resection and reconstruction for esophageal carcinoma.
Key exclusion criteria	Non-radical surgical cases.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hirofumi Kawakubo
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-6440
Email	hkawakubo@z3.keio.jp

Public contact
1st name of contact person	1st name Middle name Last name Shuhei Mayanagi
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3802
Homepage URL
Email	s.mayanagi@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
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
Email

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	2018 Year 10 Month 15 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	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 28 Day
Date of IRB	2018 Year 08 Month 27 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No related information

Management information
Registered date	2018 Year 10 Month 14 Day
Last modified on	2019 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038759