Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer

Early Gastric Cancer or Gastric Adenoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813994
• Other study ID #: 4-2012-0889
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: June 19, 2018

Study information

• Verified date: December 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Statins are commonly used as cholesterol-lowering medications and have shown effectiveness in the primary and secondary prevention of heart attack and stroke. In addition, several recent studies of human cancer cell lines and animal tumor models indicate that statins may have chemopreventive properties through the arresting of cell-cycle progression. The chemopreventive effect of statins was demonstrated in some kind of human tumors including colorectal cancer. In addition, recent one large epidemiologic study showed that statins decreased risk of gastric cancer. On the other hands, it has been well known that Helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are premalignant lesions of gastric cancer. Progression of these premalignant lesions could be limited by H. pylori eradication. In addition, a recent double blind randomization study revealed that simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate. Therefore, investigators conjecture that statins may have an adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the role of statins in gastric carcinogenesis by observing the changes of gastric inflammation under statins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 19, 2018
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age, between 20 and 70

2. Early gastric cancer or adenoma which is achieved curative resection by endoscopic submucosal dissection

3. ECOG performance status 0 or 1

Exclusion Criteria:

1. Previous subtotal gastrectomy or gastrostomy

2. Repeated endoscopic submucosal dissection

3. Two or more synchronous lesions

4. Presence of gastric or duodenal ulcer except artificial ulcer due to endoscopic submucosal dissection

5. History of drugs which are able to induce gastric ulcer including aspirin, NSAIDs, and steroid (30 days or more, within 1 year at the time of screening

6. Indication of statins, including dyslipidemia, myocardial infarction, and heart failure.

7. Develop of complications caused by endoscopic submucosal dissection, including bleeding, perforation, and pneumonia

8. LDL < 70 mg/dL

9. Allergy to statins

10. Pregnancy or breast milk feeding

11. Active infection

12. Significant cardiopulmonary disease

13. Active hepatitis or severe hepatic dysfunction

14. Severe renal dysfunction

15. Severe bone marrow dysfunction

Related Conditions & MeSH terms

• Adenoma
• Early Gastric Cancer or Gastric Adenoma
• Gastritis
• Stomach Neoplasms

Intervention

Drug:
• Arm1: Statin
Study1 (only H. pylori infected patients) Arm1: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take statins for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection. Study2 (only H. pylori non-infected patients) Arm1: In this arm2, all patients start taking statins after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection.
• Arm2: Placebo
Study1 (only H. pylori infected patients) Arm2: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take placebos for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection. Study2 (only H. pylori non-infected patients) Arm2: In this arm2, all patients start taking placebos after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of the patients with high-risk (III/IV) OLGA stages	patients with high-risk OLGA stages will be assessed by histologic examinations	6 months from the start of taking the statins