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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046598
Receipt No. 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 2022/01/11

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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
Email 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
Email kiuchi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 12 Month 20 Day
Date of IRB
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
2022 Year 01 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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