Omeprazole and Amoxicillin and/or Vitamin and Mineral Supplements and/or Garlic Supplements in Preventing Stomach Cancer in Patients With Precancerous Stomach Lesions
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Cancer; Precancerous/Nonmalignant Condition
Intervention: amoxicillin (Drug); ascorbic acid (Drug); garlic (Drug); omeprazole (Drug); selenium (Drug); vitamin E (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Mitchel H. Gail, MD, PhD, Study Chair, Affiliation: National Cancer Institute (NCI)
Summary
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.
Clinical Details
Official title: A Randomized Multi-Intervention Trial to Inhibit Precancerous Lesions in Lindqu, Shandong Province
Study design: Prevention, Randomized, Double-Blind, Placebo Control
Detailed description:
OBJECTIVES:
Primary
- Compare the effectiveness of omeprazole and amoxicillin and/or vitamin and mineral
supplementation comprising vitamin E, ascorbic acid, and selenium and/or garlic
supplementation, in terms of lowering the prevalence of severe chronic atrophic
gastritis, intestinal metaplasia, dysplasia, and gastric cancer in patients with
precancerous gastric lesions.
Secondary
- Compare the effects of these regimens on the rates of transition among the precancerous
histopathologic states in these patients.
- Compare the rate of Helicobacter pylori (H. pylori) eradication and reinfection in
patients treated with these regimens.
- Compare the effect of these regimens on blood pressure in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to Helicobacter pylori (H. pylori) antibody status (positive vs
negative) and gender. Patients with an initial H. pylori infection are randomized to 1 of 8
treatment arms (I-VIII). Patients testing negative for H. pylori are randomized to 1 of 4
treatment arms (IX-XII).
- Arm I: Patients receive oral omeprazole placebo and oral amoxicillin placebo twice daily
for 2 weeks. Three months later, patients are re-evaluated for H. pylori infection.
Patients with persistent H. pylori infection receive omeprazole placebo and amoxicillin
placebo for an additional 2 weeks. Patients also receive oral vitamin and mineral
supplement placebos comprising vitamin E placebo, ascorbic acid placebo, and selenium
placebo twice daily and oral garlic supplement placebo twice daily beginning after
completion of the initial 2-week treatment period with omeprazole and amoxicillin
placebos and continuing for 88 months.
- Arm II: Patients receive omeprazole and amoxicillin placebos and vitamin and mineral
supplement placebos as in arm I. Patients also receive an oral garlic supplement twice
daily beginning after completion of the initial 2-week treatment period with omeprazole
and amoxicillin placebos and continuing for 88 months.
- Arm III: Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also
receive oral vitamin and mineral supplements comprising vitamin E, ascorbic acid, and
selenium twice daily beginning after completion of the initial 2-week treatment period
with omeprazole and amoxicillin placebos and continuing for 88 months and garlic
supplement placebo as in arm I.
- Arm IV: Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also
receive vitamin and mineral supplements as in arm III and garlic supplement as in arm
II.
- Arm V: Patients receive oral omeprazole and oral amoxicillin twice daily for 2 weeks.
Three months later, patients are re-evaluated for H. pylori infection. Patients with
persistent H. pylori infection receive omeprazole and amoxicillin for an additional 2
weeks. Patients also receive vitamin and mineral supplement placebos and garlic
supplement placebo as in arm I.
- Arm VI: Patients receive omeprazole and amoxicillin as in arm V. Patients also receive
vitamin and mineral supplement placebos as in arm I and garlic supplement as in arm II.
- Arm VII: Patients receive omeprazole and amoxicillin as in arm V. Patients also receive
vitamin and mineral supplements as in arm III and garlic supplement placebo as in arm
I.
- Arm VIII: Patients receive omeprazole and amoxicillin as in arm V. Patients also receive
vitamin and mineral supplements as in arm III and garlic supplement as in arm II.
- Arm IX: Patients receive omeprazole and amoxicillin placebos, vitamin and mineral
supplement placebos, and garlic supplement placebo as in arm I.
- Arm X: Patients receive omeprazole and amoxicillin placebos and vitamin and mineral
supplement placebos as in arm I. Patients also receive garlic supplement as in arm II.
- Arm XI: Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also
receive vitamin and mineral supplements as in arm III and garlic supplement placebo as
in arm I.
- Arm XII: Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also
receive vitamin and mineral supplements as in arm III and garlic supplement as in arm
II.
PROJECTED ACCRUAL: Approximately 3,600 patients (approximately 2,400 randomized to arms
I-VIII [patients with Helicobacter pylori (H. pylori) infection] and 1,000 randomized to arms
IX-XII [patients without H. pylori infection]) will be accrued for this study.
Eligibility
Minimum age: 35 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: May 23, 2008
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