2024-515251-37-00RecruitingPhase 2
Effect of obesity due to the action of aspirin and its effectiveness in therapy for the treatment of colon cancer.
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 5 Nov 2024
- Lead sponsor
- Fundacion Instituto De Investigacion Sanitaria Aragon
- Diseases
- Colorectal cancer
- EU CT number
- 2024-515251-37-00
- EudraCT number
- 2021-005999-18
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a recent colon or rectal cancer diagnosis. It compares obese and non-obese patients taking low-dose aspirin for one week.
- Age
- From 18 years up to under 80 years.
- Sex
- Men and women can join.
- Disease stage
- Recent diagnosis of colon or rectal cancer, confirmed by endoscopy and a tissue study.
- Earlier treatment
- Cannot have used aspirin, NSAIDs, antiplatelet drugs, corticosteroids or misoprostol in the 15 days before diagnosis. Rectal cancer needing neoadjuvant treatment within three weeks of starting aspirin is excluded.
- Biomarker or test result
- Normal blood clotting tests. Obese group: BMI 30 or higher. Non-obese group: BMI 25 or lower.
Main reasons for not taking part
- Allergy to aspirin, other salicylates, NSAIDs or tartrazine
- Bleeding or clotting disorders, such as hemophilia
- History of stomach ulcer or other stomach or gut disease that rules out aspirin, without proton pump inhibitors
- Another cancer (not non-melanoma skin cancer) in the previous 3 years
- Active smoking, pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- Patients with nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid.
- Active smoking
- Pregnancy or breastfeeding status.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.