Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Inte… (NCT02782949) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
Honduras, Puerto Rico50 participantsStarted 2017-04-04
Plain-language summary
This randomized phase IIb trial studies how well curcumin works in preventing gastric cancer in patients with chronic atrophic gastritis and/or gastric intestinal metaplasia. Curcumin is an antioxidant compound found in plants that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-REGISTRATION INCLUSION CRITERIA
* Ability to understand and the willingness to sign a written informed consent document
* Willingness to undergo screening tests and procedures
* Willingness to provide blood and tissue samples for safety/toxicity monitoring and biomarker analyses
* Willingness to avoid the use of curcumin or any over-the-counter or prescription medications containing curcumin or curcuminoids
* REGISTRATION/RANDOMIZATION INCLUSION CRITERIA
* Histologically-confirmed chronic multifocal atrophic gastritis (MAG) and/or gastric intestinal metaplasia (GIM)
* Helicobacter pylori negative, defined as negative stool antigen testing and negative histological examination
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Aspartate transaminase (AST), alanine transferase (ALT) within institutional limits of normal or judged to be not clinically significant by the investigator
* Alkaline phosphatase within institutional limits of normal or judged to be not clinically significant by the investigator
* Platelets within institutional limits of normal or judged to be not clinically significant by the investigator
* Hemoglobin within institutional limits of normal or judged to be not clinically significant by the investigator
* White blood cells (WBC) within institutional limits of normal or judged to be not clinically significant by the investigator
* Blood urea nitrogen (BUN) within institutional limits of normal or judged to be …
What they're measuring
1
Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa