Randomized Phase II trial to evaluate the safety and efficacy of oral vitamin B 12 treatment after total gastrectomy for gastric cancer

JRCT ID: jRCTs031220328

Registered date:12/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 29/09/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Randomized controlled trial

Outcome(s)

• Primary Outcome: The incidence of vitamin B12 levels below 200 pg/ml after 48 weeks treatment

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <=12,000mm3
b) Platelet count >=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.

Exclude 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.

Related Information

• Primary Sponsor: Aya Saito
• Source(s) of Monetary Support: Advanced Medical Promotion Center