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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05402124
• Other study ID #: CRC-CHAMP01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2022
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: University of Calgary
• Contact: Robert Hilsden
• Phone: 403 592 5089
• Email: rhilsden[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Colorectal Adenoma
• Colorectal Adenomatous Polyp
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• acetylsalicylic acid delayed release tablets, 81mg
acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days

Locations

Country	Name	City	State
Canada	Forzani & Macphail Colon Cancer Screening Centre, University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of ASA	Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).	7 days
Primary	Adherence to ASA over 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.	90 days
Primary	Adherence to at least 50 percent of total prescribed dose	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.	90 days
Primary	Measurement of Adverse Events	Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).	90 days
Secondary	Factors related to uptake and adherence to ASA	Behavioral, sociodemographic and health characteristics, measured using Health & Lifestyle Questionnaire and presented as percentages.	From enrollment to 90 days
Secondary	Factors related to uptake and adherence to ASA using measurement of health related quality of life	Behavioral, sociodemographic and health characteristics, measured using Short-Form 36 Health Survey Questionnaire to measure quality of life and presented as percentages.	At enrollment
Secondary	Factors related to uptake and adherence to ASA using measurement of self efficacy	Behavioral, sociodemographic and health characteristics, measured using National Institutes of Health (NIH) Self-efficacy questionnaire and presented as percentages.	At enrollment
Secondary	Factors related to uptake and adherence to ASA	Measurement of beliefs, attitudes and values about medicines using Beliefs about Medicines questionnaire and expressed as percentages.	At enrollment
Secondary	Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers	Measurement of Adherence barriers using Adherence Barriers Questionnaire (at baseline and 3m follow-up) and expressed as percentages.	At enrollment through end of treatment at 90 days
Secondary	Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge	Measurement of knowledge about chemoprevention using Chemoprevention Questionnaires (baseline and 3m follow-up) and expressed as percentages.	At enrollment through end of treatment at 90 days