UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patients
Title of the study (Brief title)	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	yasusi rino
Organization	yokohama city university
Division name	Department of surgery
Address	fukuura kanazawa-ku yokohama
TEL	045-787-2800
Email	rino@yokohama-cu.ac.jp

Public contact
Name of contact person	toru aoyama
Organization	yokohama city university
Division name	Department of surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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