Lifestyle Intervention for Prevention of Gastric Neoplasm

Not Applicable

• Conditions: Stomach Neoplasms
• Interventions: Behavioral: Active measures of lifestyle modification

• Registration Number: NCT02679495
• Lead Sponsor: Shandong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-12
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Active measures of lifestyle modification	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.

Primary Outcome Measures

Name	Time	Method
gastric caner occurrence	4 years	gastric cancer proved by gastroscopy biopsy

Secondary Outcome Measures

Name	Time	Method
gastric tissue DNA methylation change of selected genes	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.
All cause mortality	5 years

Trial Locations

Locations (1)

Linyi People's Hospital affiliated to Shandong University; 🇨🇳 Linyi, Shandong, China