UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052591 |
|---|---|
| Receipt number | R000060014 |
| Scientific Title | Investigation of the effect of lung cancer surgery on patients' exercise tolerance |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2025/04/25 12:58:25 |
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Basic information
Public title
Investigation of the effect of lung cancer surgery on patients' exercise tolerance
Acronym
Effect of lung cancer surgery on exercise tolerance
Scientific Title
Investigation of the effect of lung cancer surgery on patients' exercise tolerance
Scientific Title:Acronym
Effect of lung cancer surgery on exercise tolerance
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of surgical procedure on postoperative exercise tolerance in lung cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking distance in 6 minutes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
six minutes walking test
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. Age 20 years or older at the time of obtaining consent
2. Those who are scheduled for lobectomy or segmental resection
3. Those who have received sufficient explanation to participate in this research, and have obtained written informed consent of their own free will based on sufficient understanding.
Key exclusion criteria
1. Patients who have difficulty walking due to quadriplegia or decreased motor ability
2. Patients who are likely to fall while walking for 6 minutes
3. In addition, patients who are judged by the research director to be inappropriate as research subjects.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University School of Medicine
Division name
Department of general thoracic surgery
Zip code
113-8431
Address
Hongo 3-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kjsuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Fukui |
Organization
Juntendo University School of Medicine
Division name
Department of general thoracic surgery
Zip code
113-8431
Address
Hongo 3-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
mrfukui@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University School of Medicine
Address
Hongo 3-1-1, Bunkyo-ku, Tokyo
Tel
03-3813-3111
igakubu.rinri1@juntendo.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
順天堂大学医学部附属順天堂医院(東京都)、国立研究開発法人 国立がん研究センター 中央病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 25 | 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
150
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060014
