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

JRCT ID: jRCTs031180231

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 11/01/2018
• Target sample size: 160
• Study type: Interventional
• Intervention(s): Randomized controlled trial

Outcome(s)

• Primary Outcome: The incidence of vitamin B12 levels below 200 pg/ml after 12 weeks treatment

Secondary Outcome

(1)The incidence of vitamin B12 levels below 200 pg/ml after 4 weeks treatment
(2)The incidence of vitamin B12 levels below 200 pg/ml after 8 weeks treatment
(3)The assessment of neurological symptom

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 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.

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: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

Related Information

• Primary Sponsor: Rino Yasushi
• Secondary ID(s): UMIN000030727