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

NCT01813994 | Completed

• 1 other identifier: 4-2012-0889
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Gastric Cancer or Gastric Adenoma

Keywords

Statin; Gastric inflammation; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

Without simvastatin

Drug: Arm2: Placebo

Statin group

EXPERIMENTAL

With simvastatin

Drug: Arm1: Statin

Interventions

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.

Statin group

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.

Also known as: C10AA-Hmg coa reductase inhibitors

Control group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 19, 2013
• Study Start: November 1, 2014
• Primary Completion: June 19, 2018
• Study Completion: June 19, 2018
• Last Updated: March 29, 2019

Record last verified: 2018-12

Locations

KR (1)