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Nonsteroidal Anti-inflammatory Drug

Aspirin for Colorectal Cancer

Q: What therapeutic benefits are typically associated with Aspirin use?

Percutaneous coronary intervention (PCI) is usually treated with aspirin, but the drug has been found to be beneficial for a variety of other medical interventions including dental procedures, inflammation and neck <a href="https://www.withpower.com/clinical-trials/pain">pain</a>.

Q: What is the aggregate figure of participants in this trial?

Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was initially posted on March 8th 2022, is presently looking for volunteers. Approximately 160 test subjects are required from a single medical centre.

Q: Is there currently any availability for this research trial?

Evidenced by the clinicaltrials.gov database, this medical trial is currently enrolling participants and has been since March 8th 2022 with its most recent update occurring on April 5th 2022.

Q: Has this research been previously conducted?

Aspirin has been the subject of clinical research since Abbott sponsored its first trials in 2005, which involved 15480 patients. Following this initial study, Aspirin was approved for Phase 4 drug use and is presently being studied at 167 different active sites situated across 1398 cities and 57 countries.

Phase < 1

Recruiting

Led By Andrew T Chan, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years and less than 55 years or greater than or equal to 65 years at the time of enrollment

ECOG performance status ≤2 (Karnofsky ≥60%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

Study Summary

This trial is looking at whether or not low doses of aspirin can help to prevent colorectal cancer.

Who is the study for?

This trial is for adults who've had at least one adenoma removed via colonoscopy in the last 9 months, are aged 18-55 or over 65, and haven't taken aspirin recently. Excluded are those with certain diseases (like inflammatory bowel disease), prior gastrointestinal cancers, recent use of NSAIDs, or conditions affecting study compliance.Check my eligibility

What is being tested?

The ASPIRED-XT study is testing low-dose Aspirin as a preventive treatment for colorectal cancer compared to a placebo. Participants will be randomly assigned to receive either Aspirin or an inactive substance to evaluate its effectiveness in reducing cancer risk.See study design

What are the potential side effects?

Aspirin may cause side effects such as increased bleeding risk, digestive tract irritation including ulcers and stomach pain, allergic reactions in some individuals, and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am either between 18 and 55 years old or 65 years and older.

Select...

I can take care of myself but might not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of ISC marker gene expression

Secondary outcome measures

ChIP-seq Analysis of Colonic Epithelium

Change in Microbiome

Change in Urinary PGE-M

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Participants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks.

Group II: Low Dose AspirinExperimental Treatment1 Intervention

Participants will be randomly assigned to aspirin group and receive a daily low dose aspirin (81 mg) for the duration of the study up to 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin

2014

Completed Phase 4

~55580

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

6,952,654 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,081 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,522 Total Patients Enrolled

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05056896 — Phase < 1

Colorectal Cancer Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT05056896 — Phase < 1

Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056896 — Phase < 1

Colorectal Cancer Research Study Groups: Placebo, Low Dose Aspirin

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic benefits are typically associated with Aspirin use?

"Percutaneous coronary intervention (PCI) is usually treated with aspirin, but the drug has been found to be beneficial for a variety of other medical interventions including dental procedures, inflammation and neck pain."

Answered by AI

What is the aggregate figure of participants in this trial?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was initially posted on March 8th 2022, is presently looking for volunteers. Approximately 160 test subjects are required from a single medical centre."

Answered by AI

Is there currently any availability for this research trial?

"Evidenced by the clinicaltrials.gov database, this medical trial is currently enrolling participants and has been since March 8th 2022 with its most recent update occurring on April 5th 2022."

Answered by AI

Has this research been previously conducted?

"Aspirin has been the subject of clinical research since Abbott sponsored its first trials in 2005, which involved 15480 patients. Following this initial study, Aspirin was approved for Phase 4 drug use and is presently being studied at 167 different active sites situated across 1398 cities and 57 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension

Andrew T. Chan, MD, MPH 2022. "ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05056896.

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