UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032256 |
|---|---|
| Receipt number | 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 22:44:52 |
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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
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
satorukc@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036465
