UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009691 |
|---|---|
| Receipt number | R000011279 |
| Scientific Title | Phase II trial of formula diet for gastric cancer surgery with obesity |
| Date of disclosure of the study information | 2013/01/10 |
| Last modified on | 2019/07/20 08:35:01 |
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Basic information
Public title
Phase II trial of formula diet for gastric cancer surgery with obesity
Acronym
Phase II trial of formula diet for gastric cancer surgery with obesity
Scientific Title
Phase II trial of formula diet for gastric cancer surgery with obesity
Scientific Title:Acronym
Phase II trial of formula diet for gastric cancer surgery with obesity
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of formula diet for gastric cancer surgery with obesity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Weight loss rate
Key secondary outcomes
Body composition
Laboratory data
Operative time
Blood loss
Morbidity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Formula diet
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
Patients with histrogically proven gastric cancer
Potentially resectable
BMI >> 25
Waist measurement >> 85cm for male
Waist measurement >> 90cm for female
Key exclusion criteria
Allergy for a soybean, milk, an egg, a peanut, and gelatin
Active infection
Uncontrolled diabetes
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Inoue |
Organization
Kansai Medical University
Division name
Surgery
Zip code
573-1191
Address
Shinmachi 2-3-1 Hirakata Osaka Japan
TEL
072-804-0101
inoueke@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Inoue |
Organization
Kansai Medical University
Division name
Surgery
Zip code
573-1191
Address
Shinmachi 2-3-1 Hirakata Osaka Japan
TEL
072-804-0101
Homepage URL
inoueke@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of surgery, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of surgery, Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Hospital
Address
Shinmachi 2-3-1 Hirakata Osaka Japan
Tel
072-804-0101
inoueke@hirakata.kmu.ac.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
関西医科大学附属枚方病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29575594
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29575594
Number of participants that the trial has enrolled
33
Results
RESULTS:
Thirty-three patients were enrolled from September 2013 to August 2015. The patients achieved a mean weight loss of 4.5% (95% confidence interval [CI]: 3.8-5.1), corresponding to 3.2？kg (95%CI: 2.7-3.7？kg). Body fat mass was significantly decreased by a mean of 2.5 kg (95%CI: 1.9-3.1), whereas skeletal muscle mass was unaffected (mean: -0.20 kg [95%CI: -0.55-0.15]). The visceral fat mass reduction rate was high as 16.8% (range, 11.6%-22.0%).
Results date posted
| 2019 | Year | 07 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with obesity who were planning to undergo laparoscopic gastrectomy for gastric cancer. Obesity was defined according to the Japanese criteria: BMI >>25kg/m2 or waist circumference >>85？cm in men and >>90cm in women.
Participant flow
The patients underwent a preoperative 20-day very low-calorie diet and received nutritional counseling.
Adverse events
Hiatal hernia 1 case
Outcome measures
Preoperative weight loss
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011279
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