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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041494
Receipt No. R000047127
Scientific Title The effects of super energy-dense oral nutritional supplements in postoperative gastric cancer patients
Date of disclosure of the study information 2020/09/04
Last modified on 2020/08/21

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Basic information
Public title The effects of super energy-dense oral nutritional supplements in postoperative gastric cancer patients
Acronym The effects of super energy-dense oral nutritional supplements in postoperative gastric cancer patients
Scientific Title The effects of super energy-dense oral nutritional supplements in postoperative gastric cancer patients
Scientific Title:Acronym The effects of super energy-dense oral nutritional supplements in postoperative gastric cancer patients
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine whether super energy-dense ONS is of clinical significance in patients for whom gastrectomy for cancer is indicated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percent change in body weight
Key secondary outcomes

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 Postoperatively, intervention with super energy-dense ONS at a dose of approximately 400 kcal/day will be administered and observed from the start of meal to 12 weeks after discharge.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1)Male or female patients aged between 20 to 85 at the time of informed consent
2)Patients who are performance status 0 or 1
3)Patients who are able to take orally
4)Patients who received gastrectomy for cancer.
5)Patients who fully understand the study procedures and have given voluntary written informed consent after a full explanation is given
Key exclusion criteria 1)Patients with allergy for milk and/or gelatin
2)Patients with non-curative resection
3)Patients with active double cancer and/or multiple cancer
4)Patients with diabetes mellitus and/or dyslipidemia
5)Patients with dementia
6)patients judged to be inappropriate by the doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Fumihiko
Middle name
Last name Hatao
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Surgery
Zip code 183-8524
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-323-5111
Email fchobi@gmail.com

Public contact
Name of contact person
1st name Fumihiko
Middle name
Last name Hatao
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Surgery
Zip code 183-8524
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-323-5111
Homepage URL
Email fchobi@gmail.com

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Department of Surgery
Institute
Department

Funding Source
Organization Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Metropolitan Tama Medical Center
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
Tel 042-323-5111
Email tamarinshou@tmhp.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
2020 Year 09 Month 04 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
2020 Year 06 Month 03 Day
Date of IRB
2020 Year 07 Month 13 Day
Anticipated trial start date
2020 Year 09 Month 04 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 21 Day
Last modified on
2020 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047127

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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