UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038794 |
|---|---|
| Receipt number | R000044231 |
| 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 |
| Date of disclosure of the study information | 2019/12/06 |
| Last modified on | 2021/06/01 09:20:10 |
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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
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
r-ogawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044231
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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