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Nonsteroidal Anti-inflammatory Drug
ASA for Ovarian Cancer Prevention
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old
ECOG performance status 0 or 1
Must not have
Subjects with concurrent use of anti-coagulants and/or anti-platelet agents
Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will investigate whether taking ASA reduces the risk of developing ovarian cancer.
Who is the study for?
This trial is for women over 18 with a high risk of ovarian cancer due to BRCA1/2 mutations, who plan to have preventive surgery within 6 months to 2 years. They must be in good health, not pregnant or breastfeeding, and not on blood thinners or anti-inflammatory drugs. Participants should agree to use effective contraception and complete questionnaires in English or French.
What is being tested?
The study tests if Acetylsalicylic acid (ASA), an anti-inflammatory drug, can prevent ovarian cancer compared to a placebo. Women will be randomly assigned ASA or placebo before their scheduled risk-reducing surgery.
What are the potential side effects?
Possible side effects of ASA include increased bleeding risk, digestive issues like stomach ulcers, allergic reactions especially in those with asthma related to salicylates or NSAIDs, and potential kidney, liver, or heart problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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I have a confirmed genetic mutation in BRCA1/2.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking blood thinners or anti-platelet medications.
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I have been treated with a PARP-inhibitor like olaparib.
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I have a condition that causes me to bleed easily.
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I currently have an active peptic ulcer.
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I have kidney, liver problems, or heart failure.
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I regularly take aspirin or NSAIDs daily for a chronic condition.
Select...
I have had both of my fallopian tubes surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Acetylsalicylic Acid (ASA)Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,750 Total Patients Enrolled
2 Trials studying Ovarian Cancer
335 Patients Enrolled for Ovarian Cancer
Apotex Inc.Industry Sponsor
8 Previous Clinical Trials
28,903 Total Patients Enrolled
Stephanie LheureuxStudy ChairUniv. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
5 Previous Clinical Trials
418 Total Patients Enrolled
Amit OzaStudy ChairUniv. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
10 Previous Clinical Trials
431 Total Patients Enrolled
2 Trials studying Ovarian Cancer
110 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer before, but it was either skin cancer, cervical cancer treated without surgery, breast cancer treated to cure, or any cancer cured over 5 years ago.You are allergic to aspirin or have a history of asthma caused by aspirin or similar drugs like ibuprofen.I have kidney, liver problems, or heart failure.I regularly take aspirin or NSAIDs daily for a chronic condition.I plan to have surgery to lower my cancer risk within 6 months to 2 years after joining the study.I am 18 years old or older.I am currently taking blood thinners or anti-platelet medications.I have been treated with a PARP-inhibitor like olaparib.I have a condition that causes me to bleed easily.I currently have an active peptic ulcer.I am fully active or can carry out light work.I can start the trial treatment within 2 days after being chosen.I can and am willing to fill out a questionnaire in English or French.I have a confirmed genetic mutation in BRCA1/2.I have had both of my fallopian tubes surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Acetylsalicylic Acid (ASA)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.