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.

First Received: August 22, 2005 Last Updated: February 1, 2010 History of Changes

Sponsor:	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 Condition	Dietary Supplement: ascorbic acid Dietary Supplement: garlic Dietary Supplement: selenium Dietary Supplement: vitamin E Drug: amoxicillin Drug: omeprazole

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

Resource links provided by NLM:

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

Show Detailed Description

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Mitchel H. Gail, MD, PhD

National Cancer Institute (NCI)

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000437906, NCI-OH-95-C-N029, BICR-OH95-C-N029
Study First Received:	August 22, 2005
Last Updated:	February 1, 2010
ClinicalTrials.gov Identifier:	NCT00134121 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

gastric cancer
precancerous condition

Additional relevant MeSH terms:

Anti-Infective Agents
Antioxidants
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Omeprazole
Anti-Bacterial Agents
Stomach Diseases
Neoplasms by Site
Vitamins
Stomach Neoplasms
Therapeutic Uses
Anti-Ulcer Agents

Micronutrients
Amoxicillin
Digestive System Neoplasms
Growth Substances
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Vitamin E
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Ascorbic Acid

ClinicalTrials.gov processed this record on February 08, 2010