gastric cancer
Conditions
Interventions
Randomized controlled trial
Sponsors
Aya Saito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1:Histologically proven adenocarcinoma of the stomach and dignosed pathological stage I to III 2:Received R0 resection 3:Age at the time of consent is 20 years or older. 4:ECOG performance status 0-2 5:seremu vitamin B12 was under 200pg/ml 6: Sufficient oral intake 7: Clinical laboratory values within 4 weeks prior to enrollment meet the following criteria to determine that major organ function is preserved. a) White blood cell count >=3,000/mm3 and =75,000/mm3 c) Hemoglobin >=8.0g/dl d) AST (GOT), ALT (GPT) <= 100IU/L e) Serum total bilirubin <= 1.5mg/dl f) Serum creatinine <= 1.5 mg/dl 8: Able to respond to medication status surveys 9:Patients were given a written explanation of the study protocol and provided their written informed consent before participating.
Exclusion criteria
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:One of the following comorbidities a) Poorly controlled diabetes mellitus b) Uncontrolled hypertension c) Cirrhosis or liver failure d) Renal failure e) interstitial pneumonia, pulmonary fibrosis, severe emphysema f) Active infection g) Heart failure, myocardial infarction, angina pectoris or significant ECG abnormalities within 6 month 5: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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of vitamin B12 levels below 200 pg/ml after 48 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incidence of vitamin B12 levels below 200 pg/ml after 8 weeks treatment 2. The incidence of vitamin B12 levels below 200 pg/ml after 16 weeks treatment 3. The incidence of vitamin B12 levels below 200 pg/ml after 24 weeks treatment 4. The incidence of vitamin B12 levels below 200 pg/ml after 32 weeks treatment 5. The incidence of vitamin B12 levels below 200 pg/ml after 40 weeks treatment1. | — |
Contacts
Public ContactToru Aoyama
Yokohama City University Hospital
Outcome results
None listed