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Effect of obesity due to the action of aspirin and its effectiveness in therapy for the treatment of colon cancer.
EU CTIS ID: 2024-515251-37-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- Treatment with methotrexate at doses of 15 mg/week or higher
- Patients with nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid.
- Rectal cancer requiring neoadjuvant treatment within three weeks of starting treatment with ASA.
See the full eligibility criteria
- 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.
- 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.
- Treatment with methotrexate at doses of 15 mg/week or higher
- Patients with nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid.
- 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
- Conditions involving serious comorbidity, excluding diabetes and including respiratory, cardiac, liver and kidney diseases.
- Active smoking
- Pregnancy or breastfeeding status.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.