Clinical trial NCT05402124: The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
Official title: The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Colorectal Adenoma
Colorectal Adenomatous Polyp
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Cancer Society (CCS)
First posted: 2022-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm, open-label, prospective cohort pilot study.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of ASA
timeFrame: 7 days
measure: Adherence to ASA over 90 days
timeFrame: 90 days
measure: Adherence to at least 50 percent of total prescribed dose
timeFrame: 90 days
measure: Measurement of Adverse Events
timeFrame: 90 days
Secondary outcomes:
measure: Factors related to uptake and adherence to ASA
timeFrame: From enrollment to 90 days
measure: Factors related to uptake and adherence to ASA using measurement of health related quality of life
timeFrame: At enrollment
measure: Factors related to uptake and adherence to ASA using measurement of self efficacy
timeFrame: At enrollment
measure: Factors related to uptake and adherence to ASA
timeFrame: At enrollment
measure: Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers
timeFrame: At enrollment through end of treatment at 90 days
measure: Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge
timeFrame: At enrollment through end of treatment at 90 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Robert Hilsden
role: PRINCIPAL_INVESTIGATOR
References: