The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study

Phase 2

• Conditions: Colorectal Cancer; Colorectal Adenoma; Colorectal Adenomatous Polyp
• Interventions: Drug: acetylsalicylic acid delayed release tablets, 81mg

• Registration Number: NCT05402124
• Lead Sponsor: University of Calgary

Brief Summary

The overall goal of this study is to develop a platform for both large-scale chemoprevention trials and real-world chemoprevention studies for colorectal cancer (CRC) prevention. The specific objectives of this proof of concept study are to:

1. Evaluate the feasibility of a real-world chemoprevention agent (CPA) intervention (3-months of daily low-dose acetylsalicylic (ASA)) in participants at increased risk for CRC (one or more high-risk adenomas removed during colonoscopy) based on participant uptake, adherence (days taking CPA), and adverse events;

2. Evaluate factors related to uptake and adherence of ASA using validated surveys and interviews.

Detailed Description

Study Design and Duration:

This is a single arm (non-randomized), open-label prospective cohort pilot study.

Screening Phase: up to 2 weeks Treatment Phase: 90 days Follow-up Phase: 90 days

Screening Phase: up to 14 days. Participants will consent to being enrolled in the study and to the use of ASA for a 90 day period. Regardless of agreement to use ASA for the entire study period, all participants will complete 6 baseline questionnaires.

Active Treatment Phase: up to 90 days. Participants that agree to the use of ASAs will be instructed to take daily ASAs for 90 days. Participants will be contacted by telephone at 1, 2, and 3 months to determine adverse events, adherence, and discontinuation. At 3 months participants will fill out a chemoprevention questionnaire and the Adherence Barriers Questionnaire (ABQ).

Follow-up Phase: 90 days. During the follow-up phase, participants will not be provided with ASA through the study nor will a specific recommendation be made to continue ASA. All participants will be contacted via telephone at the end of this period to determine the prevalence of continued use of ASA on their own.

Total study commitment will be up to 194 days. After consent, participants complete a 90 day active treatment phase followed by a 90 day follow-up phase. The trial is expected to be completed within one year.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Study Start: 2022-07
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Men or women aged 50-59 at time of signing the informed consent

2. Documented history of high-risk adenomatous polyps diagnosed within the previous 12 months:

   1. At least one villous or tubulovillous polyp of any size
   2. At least one polyp with high-grade dysplasia of any size
   3. At least one adenomatous polyp ≥1 cm in size
   4. Three or more tubular adenomas <1 cm in size

3. Not currently using ASA for another condition

Exclusion Criteria

1. Age < 50 or >= 60
2. Known allergy or hypersensitivity to ASA, salicylates or non-steroidal anti- inflammatory drugs.
3. Daily alcohol use > 3 units
4. Regular use of aspirin or non-steroidal anti-inflammatory drugs (> 2 dose/week)
5. Current use of corticosteroid (any dose) orally
6. Current use of methotrexate, valproic acid or digoxin
7. Currently taking any anti-cancer drug
8. Current use of anti-platelet agents or anticoagulants
9. Anticipated surgical procedure in the next 3 months
10. Current or past history of gastrointestinal ulcers
11. History of gastrointestinal bleeding (except hemorrhoidal or minor outlet type bleeding)
12. Known cirrhosis or hepatic impairment (for example, total bilirubin >1.25 Upper Limit of Normal, International Normalized Ratio >1.25)
13. Known bleeding disorder (hemorrhagic diathesis)
14. History of asthma or nasal polyps
15. History of colorectal cancer
16. Platelet count < 120 or > 450 (within previous 3 months)
17. Renal insufficiency (eGFR < 90 within previous 3 months)
18. History of congestive heart failure or left ventricular ejection fraction < 50 percent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASA 81mg	acetylsalicylic acid delayed release tablets, 81mg	Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days.

Primary Outcome Measures

Name	Time	Method
Measurement of Adverse Events	90 days	Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).
Uptake of ASA	7 days	Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).
Adherence to ASA over 90 days	90 days	Number of days taking ASA over a 90 day period. The time (number of days) on ASA for participants that discontinued use will be quantified.
Adherence to at least 50 percent of total prescribed dose	90 days	Percentage of participants who take at least 50 percent of total prescribed dose. Descriptive statistics will be utilized to characterize participants that adhered to ASA and participants who did not.

Secondary Outcome Measures

Name	Time	Method
Factors related to uptake and adherence to ASA	At enrollment	Measurement of beliefs, attitudes and values about medicines using Beliefs about Medicines questionnaire and expressed as percentages.
Factors related to uptake and adherence to ASA using measurement of health related quality of life	At enrollment	Behavioral, sociodemographic and health characteristics, measured using Short-Form 36 Health Survey Questionnaire to measure quality of life and presented as percentages.
Factors related to uptake and adherence to ASA using measurement of self efficacy	At enrollment	Behavioral, sociodemographic and health characteristics, measured using National Institutes of Health (NIH) Self-efficacy questionnaire and presented as percentages.
Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge	At enrollment through end of treatment at 90 days	Measurement of knowledge about chemoprevention using Chemoprevention Questionnaires (baseline and 3m follow-up) and expressed as percentages.
Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers	At enrollment through end of treatment at 90 days	Measurement of Adherence barriers using Adherence Barriers Questionnaire (at baseline and 3m follow-up) and expressed as percentages.

Trial Locations

Locations (1)

Forzani & Macphail Colon Cancer Screening Centre, University of Calgary; 🇨🇦 Calgary, Alberta, Canada