Using aspirin to prevent colorectal cancer

Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer

This study is testing if different doses of aspirin can help prevent colorectal cancer by looking at how it affects certain markers in the body.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Instituto de Investigación Sanitaria Aragón (Academic / other)
• Locations: 1 site (Zaragoza, Zaragoza)
• Trial ID: NCT03957902 on ClinicalTrials.gov

What this trial studies

This study investigates the use of acetylsalicylic acid (ASA) as a potential chemoprevention therapy for colorectal cancer (CRC). It aims to assess the direct biomarkers of aspirin action by comparing the effects of different doses of ASA on the cyclooxygenase (COX) isoenzyme COX-1 in the colorectal mucosa and platelets. The study will also measure levels of prostaglandin E2 and other biomarkers related to inflammation and tumorigenesis in CRC patients. The goal is to identify the appropriate dose and target population for effective CRC prevention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have received a recent diagnosis of rectal or colon cancer.

Not a fit: Patients with allergies to aspirin or NSAIDs, those requiring immediate neoadjuvant treatment, or those with certain gastrointestinal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a targeted approach for preventing colorectal cancer in at-risk patients using aspirin.

How similar studies have performed: Other studies have explored the use of aspirin for colorectal cancer prevention, showing promising results, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

* age ≥ 18 \< 80 years old
* recent diagnosis (\< 48h) of rectum or colon cancer, established by endoscopy and later confirmed by anatomo-pathologic study
* normal coagulation values and biochemical vales without clinically significant deviations that, at the discretion of the investigator, may interfere with the study procedures

Exclusion Criteria:

* Allergy to ASA or to any other NSAID.
* Rectal cancer requiring neoadjuvant treatment within the two weeks following the beginning of ASA treatment.
* Previous use of ASA, NSAIDs, antiplatelet agents, corticosteroids or misoprostol within the 15 days prior to diagnosis and/or anticipation of need for treatment with any of these drugs during the study period. History of peptic ulcer disease or active peptic ulcer or any other gastrointestinal disease that may be considered a contraindication to the use of ASA, without the concomitant use of proton pump inhibitors.
* Diagnosis of bleeding disorders.
* Diagnosis of cancer (excluding non-melanoma skin cancer) within the previous 3 years.
* Conditions supposing serious comorbidity, excluding diabetes, and including respiratory, cardiac, hepatic and renal diseases.
* Active smoking.
* Pregnancy or breastfeeding.
* History of drug or alcohol abuse.

Where this trial is running

Zaragoza, Zaragoza

• Hospital Clínico Universitario Lozano Blesa — Zaragoza, Zaragoza, Spain (Recruiting)

Study contacts

• Principal investigator: Ángel Lanas Arbeloa, MD — Instituto de Investigación Sanitaria Aragón
• Study coordinator: Ángel Lanas Arbeloa, MD

Conditions Colorectal Cancer