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Multi-center randomized controlled trial to evaluate oral vitamin B12 treatment for vitamin B12 deficiency after total gastrectomy in gastric cancer patients

Not Applicable
Conditions
gastric cancer
Registration Number
JPRN-jRCTs031180231
Lead Sponsor
Rino Yasushi
Brief Summary

The major findings of this study were that oral Vitamin B12 500*10^-6g/day replacement is as effective and safe as oral Vitamin B12 1500*10^-6g/day replacement for Vitamin B12 deficiency.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
78
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.

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
7:Other patients judged inappropriate by the examining physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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