None listed
Conditions
Brief summary
This study is testing if taking aspirin (also known as acetylsalicylic acid or ASA for short) may help prevent ovarian cancer in women with a high-risk gene mutation, BRCA1 or BRCA2, who plan to have the standard risk-reducing surgery. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above, and you have a gene change or mutation called BRCA1 or BRCA2, which puts you at high risk for getting ovarian cancer. Also you are scheduled, sometime in the next 6 months to 2 years, to have a surgery to reduce your risk by removing your fallopian tubes and ovaries. Study details Patients will be randomly allocated to one of two groups, Group A or Group B. Patients in Group A will be given aspirin in the form of a pill, to be taken by mouth every day for between 6 months to 2 years, before you have your scheduled risk-reducing surgery. You will have an equal chance of receiving either the low or the high dose of aspirin; low dose of aspirin is 81 mg per day and high dose of aspirin is 325 mg per day. Patients in Group B will be given a placebo in the form of a pill, to be taken by mouth every day for between 6 months to 2 years, before you have your scheduled risk-reducing surgery. A placebo is a medication with no active ingredients that is identical in appearance to the real medication. The purpose of the study is to find out whether taking aspirin (also known as acetylsalicylic acid or ASA for short) may help prevent ovarian cancer in women with a high-risk gene mutation, BRCA1 or BRCA2, who plan to have surgery to reduce the risk of developing cancer.
Interventions
Participants randomized to Group A will be given aspirin in the form of a pill, to be taken by mouth every day for between 6 months to a maximum of 2 years, before undergoing scheduled risk-reducing surgery. Participants in the intervention group will have an equal chance to receive either low dose of aspirin (81 mg) or high dose of aspirin (325 mg) once per day.
Participants will return aspirin containers to study sites to facilitate compliance checks.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the American College of Medical Genetics and Genomics (ACMG) 2015 guidelines 2. 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. Surgery should not be delayed to allow subjects to participate in the trial. Subjects must have been deemed suitable for the trial participation including surgical interventions by the qualified health care professionals who will oversee the study subjects. Subjects with a previous unilateral salpingectomy/oophorectomy for other reasons will be eligible. 3. ECOG performance status 0 or 1 4. Aged equal to or greater than 18 years old 5. Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French. The baseline assessment must be completed within required timelines, prior to randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency or literacy) to complete the questionnaire will not make the subject ineligible for the study. However, ability but unwillingness to complete the questionnaire will make the subject ineligible 6. 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. 7. Subjects must be accessible for treatment and follow-up. Subjects randomized on this trial must be treated and followed at the participating centre. Investigators must assure themselves that subjects randomized to this trial will be available for complete study participation 8. In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization 9. 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. Women of childbearing potential are defined as those who are not surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women less than 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent hysterectomy * Women aged 50 years of age or older would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses greater than 1 year ago, had chemotherapy-induced menopause
Exclusion criteria
1. 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 greater than or equal to 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 greater than 5 years. 2. Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time 3. Subjects with active bleeding or bleeding diathesis 4. Subjects with active peptic ulcer 5. Subjects with renal, hepatic or congestive heart failure 6. Subjects with concurrent use of anti-coagulants and/or anti-platelet agents 7. Subjects with prior bilateral salpingectomy 8. Subjects with history of chronic daily use of ASA (aspirin) or NSAIDs 9. Subjects with intolerance of ASA (aspirin) including subjects with a history of asthma induced by or substances with a similar action, notably non-steroidal-anti-inflammatory drugs 10. Ongoing or planned pregnancy 11. Subjects who are breastfeeding.
Outcome results
None listed