Effect of obesity due to the action of aspirin and its effectiveness in therapy for the treatment of colon cancer.
Key facts
- Where
- Zaragoza, SpanyolországSee the site
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Instituto De Investigacion Sanitaria Aragon
- Trial code
- EU 2024-515251-37-00
- Record updated
- 2024. november 5.
- Original description
To evaluate the effect of a short course (one week) of enteric-coated acetylsalicylic acid at low doses (100 mg/24h) on platelet COX-1 and COX-2 in patients diagnosed with colorectal cancer (CRC), comparing these effects in obese and non-obese patients. And evaluate the effects of another short course (one week) of different doses of acetylsalicylic acid (300 mg/day, 100 mg/12h or maintain 100 mg/24 hours) on COX-1 and COX-2 in platelets, healthy colonic tissue and tumor in patients diagnosed with CRC comparing these effects in obese and non-obese patients.Read full original descriptionShow less
Effect of obesity on the acetylation of COX1 and COX2 by aspirin as a biomarker of its effectiveness in chemoprevention and therapy in colon cancer: A Phase II Clinical Trial
To evaluate the effect of a short course (one week) of enteric-coated acetylsalicylic acid at low doses (100 mg/24h) on platelet COX-1 and COX-2 in patients diagnosed with colorectal cancer (CRC), comparing these effects in obese and non-obese patients. And evaluate the effects of another short course (one week) of different doses of acetylsalicylic acid (300 mg/day, 100 mg/12h or maintain 100 mg/24 hours) on COX-1 and COX-2 in platelets, healthy colonic tissue and tumor in patients diagnosed with CRC comparing these effects in obese and non-obese patients.
Inclusion: Age ≥ 18 years and < 80 years; Recent diagnosis (colon or rectal cancer, established by endoscopy and subsequently confirmed by anatomo-pathological study); Coagulation study within the normal range and usual biochemical parameters without clinically significant deviations that, in the opinion of the investigator, could interfere with the study procedures; In the obese group, patients with BMI ≥ 30 will be selected. In the non-obese group, patients with BMI ≤ 25 will be selected.
Exclusion: Treatment with methotrexate at doses of 15 mg/week or higher; Rectal cancer requiring neoadjuvant treatment within three weeks of starting treatment with ASA; Previous use of ASA, NSAIDs, antiplatelet agents, corticosteroids or misoprostol in the 15 days prior to diagnosis and/or anticipated need for treatment with any of these drugs during the study period; History of peptic ulcer or active peptic ulcer or any other GI disease that may be considered a contraindication to the use of ASA, without concomitant use of proton pump inhibitors; Diagnosis of bleeding disorders or gastric perforation after treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; Diagnosis of cancer (excluding non-melanoma skin cancer) in the previous 3 years; Allergy to ASA or other salicylates, non-steroidal anti-inflammatory drugs or tartrazine (cross-reaction) or any of the excipients. Allergy to other salicylates, non-steroidal anti-inflammatory drugs or tartrazine (cross-reaction) or any of the excipients; History of drug use or alcohol abuse; Diseases with coagulation disorders, mainly hemophilia or hypoprothrombinemia; Conditions involving serious comorbidity, excluding diabetes and including respiratory, cardiac, liver and kidney diseases; Patients with nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid; Active smoking; Pregnancy or breastfeeding status.