UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038779 |
|---|---|
| Receipt number | R000043829 |
| Scientific Title | Efficacy of preoperative weight loss using formula meals for obese patients with early gastrointestinal cancer |
| Date of disclosure of the study information | 2019/12/07 |
| Last modified on | 2022/06/05 09:27:14 |
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Basic information
Public title
Efficacy of preoperative weight loss using formula meals for obese patients with early gastrointestinal cancer
Acronym
Efficacy of preoperative weight loss for obese patients with early gastrointestinal cancer
Scientific Title
Efficacy of preoperative weight loss using formula meals for obese patients with early gastrointestinal cancer
Scientific Title:Acronym
Efficacy of preoperative weight loss for obese patients with early gastrointestinal cancer
Region
| Japan |
Condition
Condition
Early gastro-intestinal cancer patients with obesity
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of preoperative body weight loss program using formula diet for early gastro-intestinal cancer patients with obesity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight loss effect (kg)
Surgical outcomes
Key secondary outcomes
Nutritional state
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Early gastrointestinal cancer patient (Stage1)
BMI over 25
Key exclusion criteria
Advanced cancer
Severe renal disfunction
Severe liver disfunction
Pregnant women
Patients with mental illness who have difficulty understanding and continuing treatment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naitoh |
| Middle name | |
| Last name | Takeshi |
Organization
Tohoku University Hospital
Division name
Surgery (gastrointestinal surgery)
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, JAPAN
TEL
022-717-7205
naitot@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Imoto |
| Middle name | |
| Last name | Hirofumi |
Organization
Tohoku University Hospital
Division name
Surgery (gastrointestinal surgery)
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, JAPAN
TEL
022-717-7205
Homepage URL
hirofumi-i@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NPO Human Center 21
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, JAPAN
Tel
022-717-7000
hirofumi-i@surg.med.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | 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
10
Results
The body weight decreased to 77.4kg, BMI was 25.9, weight loss was 4.0, and the weight loss rate was 4.9%, resulting in significant weight loss compared to preoperative body weight. On the other hand, blood albumin and CONUT score showed no significant changes. The operation time was 328 min for all procedures, and blood loss was 37g. The operation was performed safely without intraoperative complications. Postoperative complications were also not observed in any of the patients.
Results date posted
| 2022 | Year | 06 | Month | 05 | Day |
Results Delayed
Results Delay Reason
The 10 cases included 6 distal, 2 proximal, and 2 total gastrectomy. Age was 68 years, male to female ratio was 9:1, initial weight was 81.7kg, and BMI was 27.2.
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 03 | Day |
Last modified on
| 2022 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043829
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
