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| Name | Class |
|---|---|
| Apotex Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylsalicylic Acid (ASA) | Active Comparator |
| |
| Placebo | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid | Drug | 81 mg PO daily or 325 mg PO daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire | 5 years | |
| Compliance of taking ASA by serum monitoring | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance of taking ASA by evaluation of treatment completion rates | 5 years | |
| Compliance of taking ASA by reasons for early discontinuation of protocol intervention. | 5 years |
Inclusion Criteria:
Exclusion Criteria:
Subjects with history of other malignancies, except:
Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time.
Subjects with active bleeding or bleeding diathesis.
Subjects with active peptic ulcer.
Subjects with renal, hepatic or congestive heart failure.
Subjects with concurrent use of anti-coagulants and/or anti-platelet agents.
Subjects with prior bilateral salpingectomy.
Subjects with history of chronic daily use of ASA or NSAIDs.
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.
Ongoing or planned pregnancy.
Subjects who are breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Amit Oza | Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada | Study Chair |
| Stephanie Lheureux | Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Prince of Wales Hospital |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo | Other | One tablet PO daily |
|
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Peter McCallum Cancer Institute | Melbourne | Victoria | 3002 | Australia |
| King Edward Memorial Hospital | Subiaco | Western Australia | 6008 | Australia |
| St John of God Subiaco | Subiaco | Western Australia | 6008 | Australia |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Clinical Research Unit at Vancouver Coastal | Vancouver | British Columbia | V5Z 1M9 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| North York General Hospital | Toronto | Ontario | M2K 1E1 | Canada |
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
| CIUSSS de l'Est-de-I'lle-de-Montreal | Montreal | Quebec | H1T 2M4 | Canada |
| CHUM-Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 3E4 | Canada |
| Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| CIUSSS de l'Estrie - Centre hospitalier | Sherbrooke | Quebec | J1H 5N4 | Canada |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |