ASA in Prevention of Ovarian Cancer (STICs and STONEs)

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Canadian Cancer Trials Group
• Collaborator: Apotex Inc.
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.