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

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.

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Key information

Conditions

Early Gastric Cancer or Gastric Adenoma Digestive System Diseases Digestive System Neoplasms Gastritis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age, between 20 and 70
Early gastric cancer or adenoma which is achieved curative resection by endoscopic submucosal dissection
ECOG performance status 0 or 1

Exclusion criteria

Previous subtotal gastrectomy or gastrostomy
Repeated endoscopic submucosal dissection
Two or more synchronous lesions
Presence of gastric or duodenal ulcer except artificial ulcer due to endoscopic submucosal dissection
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
Indication of statins, including dyslipidemia, myocardial infarction, and heart failure.
Develop of complications caused by endoscopic submucosal dissection, including bleeding, perforation, and pneumonia
LDL < 70 mg/dL
Allergy to statins
Pregnancy or breast milk feeding
Active infection
Significant cardiopulmonary disease
Active hepatitis or severe hepatic dysfunction
Severe renal dysfunction
Severe bone marrow dysfunction

Treatment and study plan

Arm1: Statin

Drug

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

Drug

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.

Other names: C10AA-Hmg coa reductase inhibitors

Primary outcomes

Proportion of the patients with high-risk (III/IV) OLGA stages

Time frame: 6 months from the start of taking the statins

patients with high-risk OLGA stages will be assessed by histologic examinations

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Mar 19, 2013
Registry last updated: Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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