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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000596
Receipt No. 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

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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
Institute AEGES study group
Institute
Department

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
URL(English) https://upload.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


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