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
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
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
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
