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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01813994
First received: March 7, 2013
Last updated: May 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Early Gastric Cancer or Gastric Adenoma
Drug: Arm1: Statin
Drug: Arm2: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Proportion of the patients with high-risk (III/IV) OLGA stages [ Time Frame: 6 months from the start of taking the statins ] [ Designated as safety issue: Yes ]
    patients with high-risk OLGA stages will be assessed by histologic examinations


Estimated Enrollment: 110
Study Start Date: February 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
Without simvastatin
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.

Placebo Comparator: Statin group
With simvastatin
Drug: 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.

Other Name: C10AA-Hmg coa reductase inhibitors

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813994

Contacts
Contact: Sang Kil Lee, MD 82-2-2228-1996 sklee@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang Kil Lee, MD    82-2-2228-1996    sklee@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01813994     History of Changes
Other Study ID Numbers: 4-2012-0889
Study First Received: March 7, 2013
Last Updated: May 26, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Statin; Gastric inflammation; Gastric cancer

Additional relevant MeSH terms:
Gastritis
Adenoma
Inflammation
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014