Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer
Conditions
Early Gastric Cancer or Gastric Adenoma
Conditions: official terms
Gastritis - Stomach Neoplasms
Conditions: Keywords
Statin; Gastric inflammation; Gastric cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: Arm1: Statin Type: Drug
Name: Arm2: Placebo Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Location
Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Sang Kil Lee, MD - 82-2-2228-1996 - sklee@yuhs.ac
Start Date
February 2013
Completion Date
May 2016
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page