NCT00578721

Trial of Aspirin and Arginine Restriction in Colorectal Cancer

Completed Phase 2 Results posted Last updated 7 July 2023

What this trial tests

Phase 2 trial testing Aspirin in Colorectal Cancer in 24 participants. Completed in 26 November 2013.

Timeline

24 September 2008

Primary endpoint
26 November 2013

26 November 2013

Quick facts

Lead sponsor	University of California, Irvine
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	24 September 2008
Primary completion	26 November 2013
Estimated completion	26 November 2013
Sites	1 location across United States

Drugs / interventions tested

• Aspirin — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

University of California, Irvine

Who can join

Adults 18 to 80, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rectal Tissue Putrescine Reduction Primary · 12 weeks

To demonstrate a \> 50% decrease in rectal tissue putrescine levels from baseline in study subjects, as a measure of polyamine reduction in the target tissue of colorectal cancer patients.

Group	Value	95% CI
325 mg Aspirin	17

Safety/Toxicity Secondary · 12 weeks

To determine the number and proportion of patients with any grade 1 or greater side effect, using Common Terminology for Adverse Events v4.0 (CTCAE)

Group	Value	95% CI
325 mg Aspirin	6

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

325 mg Aspirin

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (4 terms — click to expand)

Reaction	System	325 mg Aspirin
Fatigue	General disorders	—
Diarrhea	General disorders	—
Neuropathy	General disorders	—
Myalgia	General disorders	—

Data from ClinicalTrials.gov NCT00578721 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Aspirin in the chemoprevention of colorectal neoplasia: an overview.
   Chan AT, Arber N, Burn J, Chia WK, et al · · 2012 · cited 195× · PMID 22084361 · DOI 10.1158/1940-6207.capr-11-0391
2. Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
   Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006
3. Risk of second primary colorectal cancer among colorectal cancer cases: a population-based analysis.
   Raj KP, Taylor TH, Wray C, Stamos MJ, et al · · 2011 · cited 28× · PMID 21483654 · DOI 10.4103/1477-3163.78114
4. Meat consumption, nonsteroidal anti-inflammatory drug use, and mortality among colorectal cancer patients in the California Teachers Study.
   Zell JA, Ziogas A, Bernstein L, Clarke CA, et al · · 2010 · cited 16× · PMID 20551290 · DOI 10.1158/1940-6207.capr-09-0262
5. Phase IIa Clinical Biomarker Trial of Dietary Arginine Restriction and Aspirin in Colorectal Cancer Patients.
   Zell JA, Taylor TH, Albers CG, Carmichael JC, et al · · 2023 · cited 4× · PMID 37046763 · DOI 10.3390/cancers15072103
6. Amino acids metabolism: a potential target for cancer treatment.
   Ren S, Zhou X, Wang Z, Yuan K. · · 2025 · cited 2× · PMID 41402797 · DOI 10.1186/s12943-025-02523-3