UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011410 |
|---|---|
| Receipt number | R000013357 |
| Scientific Title | Multiinstuituional prospective study for evaluating the efficacy of oral nutritional supplements to the gastric cancer patients after gastrectomy |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2015/03/11 12:21:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multiinstuituional prospective study for evaluating the efficacy of oral nutritional supplements to the gastric cancer patients after gastrectomy
Acronym
CCOG1301
Scientific Title
Multiinstuituional prospective study for evaluating the efficacy of oral nutritional supplements to the gastric cancer patients after gastrectomy
Scientific Title:Acronym
CCOG1301
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Malnutrition after gastrectomy for gastric cancer patients is an essential problem to be solved, which may cause low rate of compliance for adjuvant chemotherapy or poor survival rate. Nutritional intervention could work those who suffer from malnutrition after gastrectomy well, showing improvement the outcome. In the current study, we will evaluate the efficacy of oral nutritional supplements using Racol® for 3 months to the gastric cancer patients after gastrectomy by measuring the body composition before surgery and 3 months after surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variation of body composition 3 months after gastrectomy
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral nutritional supplements
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Gastric cancer patients who are diagnosed to be Stage 1,2 and 3 according to the Japanease classification for gastric cancer
2. Patients who are going to undergo distal gastrectomy or total gastrectomy
Key exclusion criteria
1. Patients who need to restrict food or water intake
2. Patients who have comlicating diseases that cause body weight loss
3. Patients with contraindication for taking Racol
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University, Graduate School of Medicine
Division name
Gastroenterorogical Surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya city
TEL
052-744-2253
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Kobayashi |
Organization
Nagoya University, Graduate School of Medicine
Division name
Gastroenterorogical Surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya city
TEL
052-744-2253
Homepage URL
kobadai@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Chubu Clinical Oncology Group
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
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
| 2013 | Year | 09 | 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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2015 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013357
