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

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 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


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

Value
https://center6.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