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Lifestyle Intervention for Prevention of Gastric Neoplasm

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ClinicalTrials.gov Identifier: NCT02679495
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Lijun PENG, MD, 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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Behavioral: Active measures of lifestyle modification Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : March 12, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.



Primary Outcome Measures :
  1. gastric caner occurrence [ Time Frame: 4 years ]
    gastric cancer proved by gastroscopy biopsy


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 5 years ]
  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679495


Locations
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China, Shandong
Linyi People's Hospital affiliated to Shandong University
Linyi, Shandong, China, 276000
Sponsors and Collaborators
Shandong University
Investigators
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Study Chair: Lin Lu, MD Shandong University
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Responsible Party: Lijun PENG, MD, Dr., Shandong University
ClinicalTrials.gov Identifier: NCT02679495    
Other Study ID Numbers: 2015WS0366
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lijun PENG, MD, Shandong University:
early gastric cancer
lifestyle
Additional relevant MeSH terms:
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Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases