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A Randomized Multi-Intervention Trial to Inhibit Precancerous Gastric Lesions in Lingu, Shandong Province

NCT00339768 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3411

Last updated 2019-12-12

No results posted yet for this study

Summary

The Division of Cancer Epidemiology and Genetics is conducting a collaborative randomized multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step process of gastric carcinogenesis. The primary endpoint will not be cancer, but rather the precancerous lesions severe chronic atrophic gastritis, intestinal metaplasia, and dysplasia. The study is designed to detect a stabilizing or mild decrease in the expected age-related progression of precancerous lesions over the course of the trial. Thus the trial can be considered a study of the potential inhibitors of the process of gastric carcinogenesis. The trial will also provide an evaluation of therapy for H. pylori, including an assessment of reinfection rates, a critical need for formulating strategies for infection control in China and other developing countries. Participating in the trial are approximately 3400 adults aged 35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages in Shandong Province. Linqu appears to be an ideal setting for the trial since stomach cancer rates are among the highes in the world, precancerous gastric lesions are prevalent, and the population is stable and well characterized. These individuals will be randomly assigned (taking H. pylori positivity into account) into 8 intervention groups according to a 2(3) factorial design. The interventions are: 1) initial treatment of H. pylori infection with ameprazole and amoxicillin followed by 2) daily supplementation with a combination of alpha-tocopherol, vitamin C, and selenium; and 3) daily supplementation with garlic extracts. No serious side effects have been seen from any of the interventions to date. The study staff will continue to monitor for possible adverse reactions and the population will receive routine medical care follow-up throughout the course of the trial.

As part of the ongoing study in Linqu, all participants received an endoscopic exam in the fall of 1994. Repeat gastroscopic exams with biopsies at 7 standard gastric sites will be conducted during March to May, 1999 and March to May, 2003 to detect early cancers and to evaluate gasatric mucosal status. The subjects will be categorized according to the most advanced lesions detected in all biopsies and assigned a severity score. The three major endpoints for analysis will be: 1) prevalence of dysplasia or cancer 2) prevalence of sever chronic atrophic gastritis, intestinal metaplasia, dysplasia, or cancer; and 3) average severity score.

Conditions

  • Precancerous Gastric Lesions

Interventions

DRUG

Amoxicillin/omeprazole

To treat Helicobacter pylori infections. 2 week course of amoxicillin 1gm bid, omeprazole 20mg bid. This factorial trial also investigated a supplement of vitamin C, vitamin E and selenium and a garlic supplement.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Mitchell H Gail, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-07-01
Primary Completion
1996-06-10
Completion
1996-06-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00339768 on ClinicalTrials.gov