UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-institutional prospective randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement (Rehadays) in total gastrectomy for gastric cancer
Title of the study (Brief title)	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	Toshiyoshi Fujiwara
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Gastroenterological surgery
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	Satoru Kikuchi
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Gastroenterological surgery
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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 04 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036465