UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061561 |
|---|---|
| Receipt number | R000070438 |
| Scientific Title | Minimal Important Change of the Six-Minute Walk Distance in Patients with Esophageal Cancer Following Surgery |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/13 22:13:07 |
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Basic information
Public title
Minimal Important Change of the Six-Minute Walk Distance in Patients with Esophageal Cancer Following Surgery
Acronym
Minimal Important Change of the Six-Minute Walk Distance in Patients with Esophageal Cancer Following Surgery
Scientific Title
Minimal Important Change of the Six-Minute Walk Distance in Patients with Esophageal Cancer Following Surgery
Scientific Title:Acronym
Minimal Important Change of the Six-Minute Walk Distance in Patients with Esophageal Cancer Following Surgery
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the minimal important change in the longitudinal changes of the six-minute walk distance from before surgery to 3 weeks after surgery in patients with esophageal cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
six-minute walk distance
Key secondary outcomes
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - C30
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
Patients diagnosed with esophageal cancer or esophagogastric junction cancer
Patients aged 20 years or older at the time of informed consent
Patients able to walk independently preoperatively
Patients scheduled to undergo elective esophagectomy
Key exclusion criteria
Patients who underwent reoperation within 3 weeks after surgery
Patients with comorbidities that could affect the 6-minute walk test (6MWT) (e.g., musculoskeletal or neurological disorders causing gait impairment, such as pain or impaired balance ability)
Patients unable to understand the QLQ-C30 questionnaire due to visual or hearing impairment, or cognitive dysfunction
Patients with missing data for the 6-minute walk distance and QLQ-C30 physical functioning score at both preoperative assessment and 3 weeks postoperatively
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | Shusuke |
| Middle name | |
| Last name | Toyama |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7963
hnsnore225@gmail.com
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | toyama |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7963
Homepage URL
hnsnore225@gmail.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
kenkyurinri@ml.nagasaki-u.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
| 2026 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data on the six-minute walk distance (6MWD), QLQ-C30 physical functioning (PF) score, patient characteristics, surgical information, and postoperative complications will be collected from electronic medical records of patients who underwent esophagectomy for esophageal cancer or esophagogastric junction cancer between April 2018 and February 2026.
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070438
