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

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 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


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

Value
https://center6.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