UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000596
Receipt number R000000724
Scientific Title A randomised phaseII trial of preoperative exercise to reduce operative risk in gastric cancer patients with metabolic syndrome
Date of disclosure of the study information 2007/02/07
Last modified on 2014/08/07 15:36:22

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Basic information

Public title

A randomised phaseII trial of preoperative exercise to reduce operative risk in gastric cancer patients with metabolic syndrome

Acronym

A randomised phaseII trial of preoperative exercise for gastric cancer patients with metabolic syndrome

Scientific Title

A randomised phaseII trial of preoperative exercise to reduce operative risk in gastric cancer patients with metabolic syndrome

Scientific Title:Acronym

A randomised phaseII trial of preoperative exercise for gastric cancer patients with metabolic syndrome

Region

Japan


Condition

Condition

metabolic syndrome
gastric cancer

Classification by specialty

Endocrinology and Metabolism Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of preoperative exercise for gastric cancer patients with metabolic syndrome.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of perioperative complications

Key secondary outcomes

Changes from the base-line body weight, HDL cholesterol, operation time, intaoperative blood loss, number of dissected lymph nodes, grade of perioperative complications


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Control group: Surgery alone
Patient will be performed open gastrectomy/ total gastrectomy or laparoscopy-assisted distal/ toatl gastrectomy within 14 days after registration. Patients will receive the operation following the JGCA gastric cancer treatment guideline ver.2: standard gastrectomy or modified gastrectomy.

Interventions/Control_2

Intervention group: exercise followed by operation
type: exercise
duration: 4weeks
frequency: aerobic exercise 3-7day/week, resistance training 1-2day/week, stretch 3-7day/week
operation: same as control group

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed gastric cancer (exclude small cell carcinoma)
2) Clinical stage T1N0/T1N1/T2N0, P0, H0, M0 (Japanese Classification of Gastric Carcinoma, the 13th edition)
3) Age 20 to 75 at registration
4) ECOG PS0
5) Can walk over 200m on the flat floor and can walk up to over 2nd floor without interval
6) No ischemic change in the treadmil ECG (within 6weeks before registration)
7) Less than 1 cardiac risk in the following check list(within 4 weeks before registration)
1.History of ischemic heart disease
2.History of heart failure
3.History of cerebrovascular disease
4.Insulin therapy for diabetes
5.Preoperative serum creatinine>2.0mg/dl
8) Less than 2 respiratory risk in the following check list (within 4 weeks before registration)
1.Current smoker within 8 weeks of registration
2.Serum albumin <3.0g/dl
3.Serum BUN>30mg/dl
4.COPD(FEV1.0 of less than 80% of predicted)
9) No liver disease or Child-Pugh A(within 4 weeks before registration)
10) Suffice the following items(within 2 weeks before registration)
1.Hb>9.0g/dl
2.Plt>10x104/mm3
3.AST<100IU and ALT<100IU
11) Suffice the following 3 criteria(within 4 weeks before registration)
Waist circumference(WC)
Male, height>160cm: WC>85cm
Female or height<160cm male: WC>80cm
Excessive intraabdominal fat in CT scan
Appricable to more than 1 item of the following
TG>150mg/dl and/or HDL chol<40mg/dl
SBP>130mmHg and/or DBP<85mmHg
FBS>110mg/dl
(If already medicated for hyperlipidemia, hypertension, or Diabetes Meritus, inclusive to each item regardless of labo data)

Key exclusion criteria

1.Cannot exercise because of muscloskeletal disease
2.History of injury such as fracture within 6 months before registration
3.History or current therapy of bronchial asthma
4.History of severe pneumonia or bronchitis within 6 months before registration
5.History or current therapy of arrythmia to be treated
6.History of acute myocardial infarction within 6 months before registration
7.Uncontrolled DM (Insulin-treated patient is also applicable, if BS control is good.)

Target sample size

86


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiko Cho

Organization

Kanagawa Cancer Center

Division name

gastrointestinal surgery

Zip code


Address

1-1-2, Nakao, Asahi-ku, Yokohama

TEL

045-391-5761

Email

choharuhiko@kcch.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruhiko Cho

Organization

Kanagawa Cancer Center

Division name

gastrointestinal surgery

Zip code


Address

1-1-2, Nakao, Asahi-ku, Yokohama

TEL

045-391-5761

Homepage URL


Email

choharuhiko@kcch.jp


Sponsor or person

Institute

AEGES study group

Institute

Department

Personal name



Funding Source

Organization

Kanagawa Health Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

NPO ECRIN

Name of secondary funder(s)



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

神奈川県立がんセンター


Other administrative information

Date of disclosure of the study information

2007 Year 02 Month 07 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

Completed

Date of protocol fixation

2006 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 01 Day

Last follow-up date

2010 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

If the patients do not want to participate in randomized part, they can be enrolled to the non-randomized part (group C: non-randomized surgery alone, group D: non-randomized exercise followed by surgery).


Management information

Registered date

2007 Year 02 Month 07 Day

Last modified on

2014 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000724


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name