UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046598 |
|---|---|
| Receipt number | R000052995 |
| Scientific Title | Effects of Perioperative Rehabilitation on Blood Tumor-Suppressive MicroRNA Levels and Short- and Long-Term Outcomes in Gastrointestinal Cancer. A Single-Arm Open-Label Study |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2023/01/12 21:56:16 |
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Basic information
Public title
Effects of Perioperative Rehabilitation on Blood Tumor-Suppressive MicroRNA Levels and Short- and Long-Term Outcomes in Gastrointestinal Cancer. A Single-Arm Open-Label Study
Acronym
Effects of Perioperative Rehabilitation on Blood Tumor-Suppressive MicroRNA Levels and Short- and Long-Term Outcomes in Gastrointestinal Cancer. A Single-Arm Open-Label Study
Scientific Title
Effects of Perioperative Rehabilitation on Blood Tumor-Suppressive MicroRNA Levels and Short- and Long-Term Outcomes in Gastrointestinal Cancer. A Single-Arm Open-Label Study
Scientific Title:Acronym
Effects of Perioperative Rehabilitation on Blood Tumor-Suppressive MicroRNA Levels and Short- and Long-Term Outcomes in Gastrointestinal Cancer. A Single-Arm Open-Label Study
Region
| Japan |
Condition
Condition
gastric cancer, colorectal cancer, esophageal cancer, pancreatic cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study was to evaluate changes in blood levels of tumor-suppressive miRNAs, including miR-133b, and their effects on short- and long-term prognosis by preoperative and postoperative rehabilitation interventions in gastrointestinal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of changes in blood levels of tumor suppressive miR-133b by perioperative rehabilitation intervention in gastrointestinal cancer
Key secondary outcomes
1. Evaluation of changes in blood levels of tumor suppressive miRNAs other than miR-133b by perioperative rehabilitation intervention for gastrointestinal cancer.
2. Effect of perioperative rehabilitation intervention on sarcopenia in gastrointestinal cancer.
3. Prevention of postoperative complications by perioperative rehabilitation intervention in gastrointestinal cancer.
4. Effect of perioperative rehabilitation intervention on long-term prognosis in gastrointestinal cancer.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients scheduled for primary resection of gastrointestinal cancers will undergo preoperative rehabilitation for two weeks. During the rehabilitation stay, patients will be on a high-protein diet, medium-chain fatty acid intake, and endurance exercise at 50% to 60% of their maximum heart rate twice a day.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to undergo surgery for gastrointestinal cancer from the date of approval until March 31th in 2024.
Patients who can provide written consent to participate in this study of their own free will.
Patients who are between 20 and 74 years of age at the time of consent.
Any gender.
Patients whose diagnosis has been disclosed.
Patients who do not have clinically unresectable factors at the time of their first outpatient visit to the Department of Gastrointestinal Surgery.
Key exclusion criteria
Patients with a performance status of 2 or higher.
Patients who have undergone heart or lung surgery.
Patients with a history of ischemic heart disease, arrhythmia, or pacemaker implantation.
Patients who are judged to be unable to be rehabilitated due to musculoskeletal diseases or trauma.
Patients with other malignant tumors.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Eigo |
| Middle name | |
| Last name | Otsuji |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery, Department of Surgery
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku Kyoto, JAPAN
TEL
075-251-5527
otsuji@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kiuchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery, Department of Surgery
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku Kyoto, JAPAN
TEL
075-251-5527
Homepage URL
kiuchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku Kyoto, JAPAN
Tel
075-251-5527
kiuchi@koto.kpu-m.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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 17 | 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
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2022 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052995
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