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Recruitment status Terminated
Unique ID issued by UMIN UMIN000032256
Receipt No. R000036465
Scientific Title Multi-institutional prospective randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement (Rehadays) in total gastrectomy for gastric cancer
Date of disclosure of the study information 2018/07/01
Last modified on 2018/10/15

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Basic information
Public title Multi-institutional prospective randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement (Rehadays) in total gastrectomy for gastric cancer
Acronym Randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement in total gastrectomy
Scientific Title Multi-institutional prospective randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement (Rehadays) in total gastrectomy for gastric cancer
Scientific Title:Acronym Randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement in total gastrectomy
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy of postoperative exercise and oral nutritional suppliment on body weight loss and muscle mass loss after total gastrectomy for gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Body weight loss rate at 4-6 weeks after total gastrectomy
Key secondary outcomes 1.compliance with oral nutritional supplement
2.muscle mass loss rate
3.body composition change
4.nutrition related blood parameters (serum total protein, serum albumin, total cholesterol, total lymphocyte number, c-reactive protein, multifunctionality and exhaustion of lymphocyte)
5.postoperative complication
6.quolity of life
7.postoperative bodyweight and body composition changes at 3m, 6m and 12m.
8.compliance with adjuvant chemotherapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food Other
Interventions/Control_1 oral nutritional supplement
In the exercise and nutritional support group, the patients drink 2 packs of oral nutritional supplements (Rehadays) per day between postoperative day (POD) 3 and 30.
Interventions/Control_2 exercise
1. walking more than 5000 steps (40 minutes)
2. 2 sets of 10 repetitions of squats
3. 2 sets of 10 repetitions of standing tiptoe
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.gastric cancer patients who are planned to undergo total gastrectomy
2.patient's age is over than 20 years old
3.clinical stage 1, 2 or 3 and curative resection at the end of surgery
4.Eastern Cooperative Oncology Group performance status of 0, 1
5.ability for oral intake
6.Before participation, patients receive information about the study and provide their written consent
Key exclusion criteria 1.diagnosis of other organ cancer
2.contraindications to Rehadays (allergy to milk or coffee)
3.active infection or inflamation
4.uncontrolled diabetes
5.pregnancy or intention for pregnancy
6.Immunodeficiency
7.clinically relevant cardiac or pulmonary disease
8.history of clinically relevant mental disorder or central nervous system disorder
9.Unsuitable patients for enrollment judged by the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Gastroenterological surgery
Zip code
Address 2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7257
Email toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Kikuchi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Gastroenterological surgery
Zip code
Address 2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7257
Homepage URL
Email satorukc@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization scholarship donation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kochi Health Sciences Center
Name of secondary funder(s) Hiroshima City Hiroshima Citizens Hospital

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岡山大学病院(岡山県)、高知医療センター(高知県)、広島市立広島市民病院(広島県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 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 Terminated
Date of protocol fixation
2018 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
2021 Year 06 Month 30 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036465

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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