Effect of obesity due to the action of aspirin and its effectiveness in therapy for the treatment of colon cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Instituto De Investigacion Sanitaria Aragon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Digestive System Diseases [C06]

Trial duration

5 Nov 2024 → ongoing

Decision date (initial)

2024-11-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515251-37-00

EudraCT number

2021-005999-18

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacodynamic

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.

Secondary objectives 5

1. To evaluate the effect of ASA on indirect biomarkers of its action at a systemic level: the platelet activity of COX-1 will be investigated through TXB2 levels in serum; and platelet activity in vivo through urinary levels of TX-M.
2. To investigate the role of inflammatory and anti-inflammatory cytokines in platelet activation in this environment.
3. To investigate the degree of COX-1 and COX-2 acetylation in normal and tumor tissue after exposure of patients to ASA in the phase 2 study.
4. To evaluate the effect of ASA on PGE2 and P-S6 levels in the CRC mucosa.
5. To evaluate the effect of ASA on the levels of specialized lipid markers including those derived from ASA (AT-SPMs).

Conditions and MedDRA coding

Colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 18 years and < 80 years.
2. Recent diagnosis (colon or rectal cancer, established by endoscopy and subsequently confirmed by anatomo-pathological study).
3. 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.
4. In the obese group, patients with BMI ≥ 30 will be selected. In the non-obese group, patients with BMI ≤ 25 will be selected.

Exclusion criteria 13

1. 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.
2. Rectal cancer requiring neoadjuvant treatment within three weeks of starting treatment with ASA.
3. 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.
4. 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.
5. Diagnosis of bleeding disorders or gastric perforation after treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
6. Diagnosis of cancer (excluding non-melanoma skin cancer) in the previous 3 years
7. Conditions involving serious comorbidity, excluding diabetes and including respiratory, cardiac, liver and kidney diseases.
8. Active smoking
9. Pregnancy or breastfeeding status.
10. History of drug use or alcohol abuse.
11. Diseases with coagulation disorders, mainly hemophilia or hypoprothrombinemia.
12. Treatment with methotrexate at doses of 15 mg/week or higher
13. Patients with nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Effect of two courses (1 week/course) of different doses of ASA on COX-1 and COX-2 in patients diagnosed with colorectal cancer

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Instituto De Investigacion Sanitaria Aragon

Sponsor organisation

Fundacion Instituto De Investigacion Sanitaria Aragon

Address

Edificio Ciba, Avenida De San Juan Bosco 13 Avenida De San Juan Bosco 13

City

Zaragoza

Postcode

50009

Country

Spain

Scientific contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria Aragon

Contact name

Clinical Investigation Unit

Public contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria Aragon

Contact name

Clinical Investigation Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications