UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004650 |
|---|---|
| Receipt number | R000005541 |
| Scientific Title | Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2014/08/29 09:17:55 |
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Basic information
Public title
Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Acronym
Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Scientific Title
Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Scientific Title:Acronym
Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Region
| Japan | Asia(except Japan) |
Condition
Condition
gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether ONS is of clinical significance (effect to general condition) in patients for whom total gastrectomy and distal gastrectomy for cancer is indicated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change and amount of change in body weight (amount of change in BMI)
Key secondary outcomes
1)Percent change and amount of change in grip strength
2)QOL (EORTC QLQ-C30)
3)Percentage of completed chemotherapy (only patients receiving chemotherapy)
4)Nutritional indexes
5)Body composition
6)Occurrence of adverse events of ONS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Postoperatively, intervention with 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
We assess a control group in the same way for 12 weeks.
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
1)Male or female patients aged 20 years and older at the time of informed consent
2)Patients who are able to take orally
3)Patients who will receive radical total gastrectomy for cancer irrespective of technique
4) Patients who will receive radical distal gastrectomy for cancer irrespective of technique
4)Patients who have not received pretreatment for gastric cancer (radiation, chemotherapy, and hormonal therapy etc.)
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 ileus
2)Patients with no residual intestinal function
3)Patients with severe liver disorder
AST (GOT) or ALT (GPT) ≥ 2.5 times the upper limit of normal at hospital
4)Patients with severe renal disorder
Cr ≥ 2.0 mg/dL
5)Patients with abnormal glucose metabolism such as severe diabetes mellitus : HbA1c ≥ 7.0%
6)Patients with allergy to any ingredient of milk, wheat, soy bean, or salmon
7)Pregnant women, women suspected of being pregnant, or lactating women
8)Patients with active double cancer and/or multiple cancer
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SETO, Yasuyuki |
Organization
THE UNIVERSITOY OF TOKYO
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HATAO, Fumihiko |
Organization
THE UNIVERSITOY OF TOKYO
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
fchobi@gmail.com
Sponsor or person
Institute
THE UNIVERSITOY OF TOKYO
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2014 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005541
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