Trial of Aspirin and Arginine Restriction in Colorectal Cancer
Status:
Active, not recruiting
Trial end date:
2021-10-21
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to understand the effects of oral aspirin taken daily
with an arginine-restricted diet on certain colorectal cancer biomarkers in treated
colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence
and for development of secondary colorectal cancers in the future. Specific chemicals
(polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help
understand a person's risk for developing colorectal cancer. Specific biomarkers associated
with colorectal cancer have been identified in prior laboratory studies. By measuring these
predefined biomarkers before and after the study intervention, we can assess how they are
affected by the intervention, and gain knowledge about their usefulness in colorectal cancer
patients on clinical trial.
This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily
with an arginine-restricted diet designed to reduce arginine intake by at least 30% during
the 12-week study period. The biomarkers will be obtained from patient by performing
endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy
(taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are
done to evaluate changes in tissue content that may relate to early events in colon cancer
formation. This was the procedure used to diagnose your condition initially. There will be 24
patients enrolled into this study performed through University of California Irvine Medical
Center.