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Omeprazole and Amoxicillin and/or Vitamin and Mineral Supplements and/or Garlic Supplements in Preventing Stomach Cancer in Patients With Precancerous Stomach Lesions
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00134121
  Purpose

RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from forming, growing, or coming back. The use of omeprazole and amoxicillin and/or vitamin and mineral supplements and/or garlic supplements may prevent stomach cancer.

PURPOSE: This randomized clinical trial is studying how well giving omeprazole and amoxicillin and/or vitamin and mineral supplements and/or garlic supplements works in preventing stomach cancer in patients with precancerous stomach lesions.


Condition Intervention
Gastric Cancer
Precancerous/Nonmalignant Condition
Drug: amoxicillin
Drug: ascorbic acid
Drug: garlic
Drug: omeprazole
Drug: selenium
Drug: vitamin E

MedlinePlus related topics: Cancer Dietary Supplements Minerals Stomach Cancer
Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Selenium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Ascorbic acid Allium sativum extract
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: A Randomized Multi-Intervention Trial to Inhibit Precancerous Lesions in Lindqu, Shandong Province

Further study details as provided by National Cancer Institute (NCI):

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Gastroscopic results and histopathology must have been obtained through prior participation in an endoscopic survey conducted in Linqu County, Shandong Province, China
  • Resident of Linqu County, Shandong Province, China, an area with high gastric cancer risk

PATIENT CHARACTERISTICS:

Age

  • 35 to 65

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • No history of bleeding disorder

Hepatic

  • No liver disease

Renal

  • No renal disease

Cardiovascular

  • No heart failure

Pulmonary

  • No emphysema

Other

  • Not pregnant
  • No allergy to penicillin or similar drugs
  • No cancer except resected nonmelanoma skin cancer
  • No other life-threatening illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior treatment for Helicobacter pylori (H. pylori) infection
  • No concurrent regular use of vitamin or mineral supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134121

Sponsors and Collaborators
Investigators
Study Chair: Mitchel H. Gail, MD, PhD National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000437906, NCI-OH-95-C-N029, BICR-OH95-C-N029
Study First Received: August 22, 2005
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00134121  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
gastric cancer
precancerous/nonmalignant condition

Study placed in the following topic categories:
Amoxicillin
Tocopherol acetate
Digestive System Neoplasms
Precancerous Conditions
Gastrointestinal Diseases
Omeprazole
Stomach cancer
Alpha-Tocopherol
Tocopherols
Selenium
Vitamin E
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Ascorbic Acid

Additional relevant MeSH terms:
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Anti-Ulcer Agents
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009