ASPirin Intervention for the REDuction of Colorectal Cancer Risk

NCT02394769 | Active Not Recruiting Results DMC

• 2 other identifiers: 14-496R01CA137178
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is investigating the use of aspirin as a potential chemopreventive agent to reduce risk of colorectal cancer

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Urinary Prostaglandin Metabolites (PGE-M)

  Measured using liquid chromatography/mass spectrometry

  8-12 weeks

Secondary Outcomes (4)

• Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker

  8-12 weeks

• Chromatin Binding

  8-12 weeks

• Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC)

  8-12 weeks

• Spectral Biomarkers of Colorectal Cancer

  8-12 weeks

Study Arms (3)

Placebo (For Aspirin)

PLACEBO COMPARATOR

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.

Drug: Placebo for Aspirin

Low Dose Aspirin

ACTIVE COMPARATOR

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Drug: Aspirin

Standard Dose Aspirin

ACTIVE COMPARATOR

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Drug: Aspirin

Interventions

Aspirin DRUG

Also known as: 2-Acetylsalicylic Acid, ASA

Low Dose Aspirin; Standard Dose Aspirin

Placebo for Aspirin DRUG

Placebo (For Aspirin)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent screening or surveillance colonoscopy at MGH within the last 9 months with removal of at least one adenoma.
• Age 18-80 years.
• This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of a daily aspirin regimen over the age of 80 have not yet been well-characterized.
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
• Not currently taking aspirin (any dose) within the last 6 months.
• The effects of aspirin on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Use of any non-aspirin non-steroidal anti-inflammatory drug (NSAID) at any dose at least three times a week during the two months prior to randomization.
• Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis
• Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of non- melanoma skin) in which there has been any active treatment within the last three years
• Participants who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to aspirin.
• Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
• Any adenoma that was not completely removed during previous colonoscopy.
• History of aspirin intolerance, bleeding diathesis, peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy.
• Inability or unwillingness to abstain from non-protocol use of aspirin or NSAIDs or to provide blood, urine, or stool samples or colon biopsies during the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breastfeeding.
• Pregnant women are excluded from this study because aspirin is an FDA Category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin.
• Participant must be able to swallow pills.
• Participant is taking any anticoagulant agent (e.g. warfarin) or antiplatelet agent (e.g. clopidogrel).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Drew DA, Chin SM, Gilpin KK, Parziale M, Pond E, Schuck MM, Stewart K, Flagg M, Rawlings CA, Backman V, Carolan PJ, Chung DC, Colizzo FP 3rd, Freedman M, Gala M, Garber JJ, Huttenhower C, Kedrin D, Khalili H, Kwon DS, Markowitz SD, Milne GL, Nishioka NS, Richter JM, Roy HK, Staller K, Wang M, Chan AT. ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial. Trials. 2017 Feb 1;18(1):50. doi: 10.1186/s13063-016-1744-z.

  PMID: 28143522 BACKGROUND

• Drew DA, Schuck MM, Magicheva-Gupta MV, Stewart KO, Gilpin KK, Miller P, Parziale MP, Pond EN, Takacsi-Nagy O, Zerjav DC, Chin SM, Mackinnon Krems J, Meixell D, Joshi AD, Ma W, Colizzo FP, Carolan PJ, Nishioka NS, Staller K, Richter JM, Khalili H, Gala MK, Garber JJ, Chung DC, Yarze JC, Zukerberg L, Petrucci G, Rocca B, Patrono C, Milne GL, Wang M, Chan AT. Effect of Low-dose and Standard-dose Aspirin on PGE2 Biosynthesis Among Individuals with Colorectal Adenomas: A Randomized Clinical Trial. Cancer Prev Res (Phila). 2020 Oct;13(10):877-888. doi: 10.1158/1940-6207.CAPR-20-0216. Epub 2020 Jul 27.

  PMID: 32718943 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Andrew T. Chan, MD, MPH
• Organization: Massachusetts General Hospital

achan@partners.org

(617) 726-3212

Study Officials

• Andrew T Chan, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: July 6, 2015
• Primary Completion: April 11, 2019
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 4, 2025
• Results First Posted: March 23, 2021

Record last verified: 2025-11

Locations

US (1)