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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038779
Receipt No. 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 2019/12/07

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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
Email 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
Email hirofumi-i@surg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email 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
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 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
2019 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043829

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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