Lifestyle Intervention for Prevention of Gastric Neoplasm

November 3, 2022 updated by: Lijun PENG, MD, Shandong University

Positive Lifestyle Interventions for the Prevention of Gastric Pre-cancer and Cancer Occurrences in Patients With Chronic Atrophy Gastritis and Reccurence of Gastric Cancer After Endoscopic Resection

The purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Linyi, Shandong, China, 276000
        • Linyi People's Hospital affiliated to Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of chronic atrophy gastritis proved by gastroscopy biopsy pathology or early gastric cancer patients who have recieved endoscopic resection
  • have one or several bad lifestyle habits such as eating too much salt, eating too few fruits, smoking, drinking wine, and lack of sleep.

Exclusion Criteria:

  • patients who refuse to change lifestyle according to the trial plan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lifestyle intervention
A better lifestyle that are supposed to prevent gastric cancer occurrence are advised to patients. Measures includes dietary change and cessation of smoking and alcohol abuse. Behavioural and cognitive strategies from investigators are performed to patients to ensure adherence to established intervention.
Behavioral: Active measures of lifestyle modification
No Intervention: No intervention
No meassures are taken to change life style of enrolled patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric caner occurrence
Time Frame: 4 years
gastric cancer proved by gastroscopy biopsy
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 5 years
5 years
gastric tissue DNA methylation change of selected genes
Time Frame: 4 years
All patients have gastric biopsy through gastroscopy at the enrollment time and the last follow-up. DNA methylation status of selected genes are tested.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Study Chair: Lin Lu, MD, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015WS0366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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