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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030727
Receipt No. 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

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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
Email 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
Email t-aoyama@lilac.plala.or.jp

Sponsor
Institute yokohama city university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035085

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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