UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study on the change of muscle strength, muscle mass, physical performances, and other parameters in perioperative esophageal cancer patients
Acronym	A clinical study on the change of muscle strength, muscle mass, physical performances, and other parameters during perioperative period
Scientific Title	A clinical study on the change of muscle strength, muscle mass, physical performances, and other parameters in perioperative esophageal cancer patients: a multicenter, single arm, prospective observational study
Scientific Title:Acronym	A clinical study on the change of muscle strength, muscle mass, physical performances, and other parameters in perioperative esophageal cancer patients
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the change of muscle strength, muscle mass, physical performances, and other parameters during the perioperative period of esophagectomy
Basic objectives2	Others
Basic objectives -Others	Observational
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle strength, muscle mass, physical performances, respiratory functions, ADL, and body weight
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who are scheduled to undergo esophagectomy (2) Patients of 20 years or older at the time of informed consent (3) Patients who can provide written informed consent
Key exclusion criteria	(1) Patients with the Performance Status on the Eastern Cooperative Oncology Group of 3 or greater (2) Patients with severe complications such as poorly-controlled diabetes, hypertension, etc. (3) Patients with muscular diseases including active myopathy or muscular dystrophy (4) Patients who have history of lower limb fractures within 6 months before the day of informed consent (5) Patients who cannot keep standing or sitting, walk, and etc. due to severe disabilities or diseases (e.g., stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral neuropathy, intermittent claudication due to advanced peripheral vascular disease with poorly-controlled pain, spinal stenosis, or severe osteoarthritis of the knee or hip, and others) (6) Patients who cannot continue deep breathing due to respiratory diseases (7) Patients with chronic obstructive pulmonary disease whose severity grade is 3 or greater on the modified medical research council dyspnea scale (The 5th JRS Guidelines for the Management of Chronic Obstructive Pulmonary Disease) (8) Pregnant and breastfeeding patients (9) Patients who are participated in a clinical trial or clinical study and received an unapproved drug within 16 weeks before the day of informed consent (10) Patients who are deemed unsuitable for inclusion in this study for any other reason based on assessment by the investigator or sub-investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Ogawa
Organization	Nagoya city university graduate school of medical sciences
Division name	Gastroenterological surgery
Zip code	467-0001
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Japan
TEL	052-853-8226
Email	r-ogawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Ogawa
Organization	Nagoya city university graduate school of medical sciences
Division name	Gastroenterological surgery
Zip code	4670001
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Japan
TEL	052-853-8226
Homepage URL
Email	r-ogawa@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	.
Address	.
Tel	052-858-7215
Email	clinical_research@med.nagoya-cu.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	2019 Year 12 Month 06 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	2019 Year 10 Month 09 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2019 Year 12 Month 12 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 04 Month 15 Day
Date trial data considered complete	2021 Year 04 Month 19 Day
Date analysis concluded	2021 Year 05 Month 24 Day

Other
Other related information	A prospective study

Management information
Registered date	2019 Year 12 Month 05 Day
Last modified on	2021 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044231