UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041494 |
|---|---|
| Receipt number | 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 | 2023/08/23 15:25:25 |
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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
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
fchobi@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Department of Surgery
Institute
Department
Personal name
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
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
14
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
Main results already published
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
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047127
| Research Plan | |
|---|---|
| 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 |
