UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031262
Receipt number R000035656
Scientific Title Feasibility study on nutrition and exercise intervention after gastrectomy for gastric cancer
Date of disclosure of the study information 2018/02/13
Last modified on 2023/08/21 07:50:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Feasibility study on nutrition and exercise intervention after gastrectomy for gastric cancer

Acronym

Feasibility study on nutrition and exercise intervention after gastrectomy

Scientific Title

Feasibility study on nutrition and exercise intervention after gastrectomy for gastric cancer

Scientific Title:Acronym

Feasibility study on nutrition and exercise intervention after gastrectomy

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety of early nutrition and exercise intervention after gastrectomy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Compliance of nutritional supplement and achievement rate of exercise for 90 days after surgery.

Key secondary outcomes

The change of lean body mass, walking speed, body weight, nutritional index at preoperative state, 7 days, 30 days and 90 days after surgery.
Incidence of complication and the rate of re-admission.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food Maneuver

Interventions/Control_1

Oral supplementation of 1 pack of leucine rich amino acid supplement per day for 90 days from the 2nd day after surgery.
Rehabilitation is carried out every day in line with behavior objective from the next day after surgery.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

i) Histologically proven adenocarcinoma of the stomach.
ii) R0 resection is possible by gastrectomy
iii) Any stage of gastric cancer
iv) ECOG performance status 0-1.
v) Planned surgery and no restriction on the procedure of gastrectomy.
vi) Written informed consent.

Key exclusion criteria

i) Synchronous cancer
ii) Severe heart and pulmonary disorder
iii) Preoperative tube feeding is needed due to poor oral intake.
iv) Allergic reaction to apple.
v) Oral nutritional supplements are taken.
vi) When the examining physician judges that she/he is not adequate for the study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Souya
Middle name
Last name Nunobe

Organization

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Division name

Department of Gastroenterological Surgery,

Zip code

135-8550

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

TEL

03-3520-0111

Email

souya.nunobe@jfcr.or.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Ida

Organization

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Division name

Department of Gastroenterological Surgery,

Zip code

135-8550

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

TEL

03-3520-0111

Homepage URL


Email

satoshi.ida@jfcr.or.jp


Sponsor or person

Institute

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Institute

Department

Personal name



Funding Source

Organization

Self-sustaining fund

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Ajinomoto Co., Inc.


IRB Contact (For public release)

Organization

Cancer Institute Hospital, Japanese Foundation for Cancer Research

Address

3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

Tel

0335200111

Email

med.shinsa@jfcr.or.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

公益財団法人がん研究会有明病院 (東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 13 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

No longer recruiting

Date of protocol fixation

2018 Year 02 Month 01 Day

Date of IRB

2017 Year 10 Month 11 Day

Anticipated trial start date

2018 Year 02 Month 14 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry

2023 Year 09 Month 30 Day

Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2023 Year 08 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name