UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030727 |
|---|---|
| Receipt number | R000035085 |
| Scientific Title | Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patients |
| Date of disclosure of the study information | 2018/01/10 |
| Last modified on | 2018/04/29 08:25:49 |
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Basic information
Public title
Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patients
Acronym
Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patients
Scientific Title
Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patients
Scientific Title:Acronym
Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patients
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compared the efficacy of oral vitamin
B12 replacement (500) to that of oral vitamin B12 replacement (1500)in patients with vitamin B12 deficiency after total
gastrectomy for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of vitamin B12 levels below 200 pg/ml after 12 weeks treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vitamin B12 1500
Interventions/Control_2
Vitamin B12 500
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:Histologically proven adenocarcinoma of the stomach and dignosed pathological stage I to III
2:Received R0 resection
3:Age ranging between 20 and 80 years
4:ECOG performance status 0-2
5:seremu vitamin B12 was under 200pg/ml
6:Peripheral neuropathy with vitamin B12
7:Sufficient oral intake
8:Sufficient organ function
9:Answer toPNQ test
10:Patients were given a written explanation of the study protocol and provided their written informed consent before participating.
Key exclusion criteria
1:Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included).
2:Allergic reaction to vitamin B12
3:Systemic treatment with vitamin B12
4:Peripheral neuropathy with other causes
5:Received adjuvant chemotherapy for gastric cancer
6:Any other medical conditions that made a patient unsuitable for inclusion in the study according to the opinion of the investigator were also considered to be exclusion criteria for this study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yasusi rino |
Organization
yokohama city university
Division name
Department of surgery
Zip code
Address
fukuura kanazawa-ku yokohama
TEL
045-787-2800
rino@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | toru aoyama |
Organization
yokohama city university
Division name
Department of surgery
Zip code
Address
fukuura kanazawa-ku yokohama
TEL
045-787-2800
Homepage URL
t-aoyama@lilac.plala.or.jp
Sponsor or person
Institute
yokohama city university
Institute
Department
Personal name
Funding Source
Organization
Department of surgery
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 11 | 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
| 2018 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035085
