ASA in Prevention of Ovarian Cancer (STICs and STONEs)
- Conditions
- Ovarian Cancer Prevention
- Interventions
- Other: Placebo
- Registration Number
- NCT03480776
- Lead Sponsor
- Canadian Cancer Trials Group
- Brief Summary
While ASA is not a cancer medication, research suggests that taking ASA reduces the probability of getting many types of cancer because of its anti-inflammatory action. Inflammation in the ovaries during ovulation is thought to contribute to the development of ovarian cancer, and, because ASA is an anti-inflammatory medication, it may help to prevent it.
- Detailed Description
The standard or usual treatment for women with a high risk gene mutation, BRCA1 or BRCA2, is to have risk-reducing surgery to remove the fallopian tubes and ovaries (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) after they have decided not to have more children naturally.
Acetylsalicylic Acid (ASA) is a safe, well tolerated drug taken by mouth. ASA has been available for over 100 years and has been used mainly to relieve fever and pain, but also as an anti-inflammatory medication in order to reduce inflammation (swelling).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 117
- Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines
- Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families
- ECOG performance status 0 or 1
- Age ≥ 18 years old
- Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French.
- Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate
- Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre.
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization
- Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication
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Subjects with history of other malignancies, except:
- adequately treated non-melanoma skin cancer;
- curatively treated in-situ cancer of the cervix;
- previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization; endocrine therapy for breast cancer is allowed at any time.
- other solid tumours curatively treated with no evidence of disease for > 5 years.
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Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time.
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Subjects with active bleeding or bleeding diathesis.
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Subjects with active peptic ulcer.
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Subjects with renal, hepatic or congestive heart failure.
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Subjects with concurrent use of anti-coagulants and/or anti-platelet agents.
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Subjects with prior bilateral salpingectomy.
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Subjects with history of chronic daily use of ASA or NSAIDs.
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Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs.
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Ongoing or planned pregnancy.
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Subjects who are breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Acetylsalicylic Acid (ASA) Acetylsalicylic acid -
- Primary Outcome Measures
Name Time Method Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test 5 years
- Secondary Outcome Measures
Name Time Method Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire 5 years Compliance of taking ASA by serum monitoring 5 years
Trial Locations
- Locations (17)
King Edward Memorial Hospital
🇦🇺Subiaco, Western Australia, Australia
Peter McCallum Cancer Institute
🇦🇺Melbourne, Victoria, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
St John of God Subiaco
🇦🇺Subiaco, Western Australia, Australia
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
Women's College Hospital
🇨🇦Toronto, Ontario, Canada
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Clinical Research Unit at Vancouver Coastal
🇨🇦Vancouver, British Columbia, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
CIUSSS de l'Est-de-I'lle-de-Montreal
🇨🇦Montreal, Quebec, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier
🇨🇦Sherbrooke, Quebec, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada