Back to resultsLifestyle Intervention for Prevention of Gastric Neoplasm
Primary Purpose
Stomach Neoplasms
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active measures of lifestyle modification
Sponsored by
About this trial
This is an interventional prevention trial for Stomach Neoplasms focused on measuring early gastric cancer, lifestyle
Eligibility Criteria
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
Sites / Locations
- Linyi People's Hospital affiliated to Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lifestyle intervention
No intervention
Arm Description
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.
No meassures are taken to change life style of enrolled patients.
Outcomes
Primary Outcome Measures
gastric caner occurrence
gastric cancer proved by gastroscopy biopsy
Secondary Outcome Measures
All cause mortality
gastric tissue DNA methylation change of selected genes
All patients have gastric biopsy through gastroscopy at the enrollment time and the last follow-up. DNA methylation status of selected genes are tested.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02679495
Brief Title
Lifestyle Intervention for Prevention of Gastric Neoplasm
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
early gastric cancer, lifestyle
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No meassures are taken to change life style of enrolled patients.
Intervention Type
Behavioral
Intervention Name(s)
Active measures of lifestyle modification
Primary Outcome Measure Information:
Title
gastric caner occurrence
Description
gastric cancer proved by gastroscopy biopsy
Time Frame
4 years
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
5 years
Title
gastric tissue DNA methylation change of selected genes
Description
All patients have gastric biopsy through gastroscopy at the enrollment time and the last follow-up. DNA methylation status of selected genes are tested.
Time Frame
4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Lu, MD
Organizational Affiliation
Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Linyi People's Hospital affiliated to Shandong University
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Lifestyle Intervention for Prevention of Gastric Neoplasm
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