A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women With BRCA 1/2 Mutations (STICs and STONEs)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    414
  • sponsor
    Canadian Cancer Trials Group
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Updated on 27 October 2022
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Accepts healthy volunteers

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.

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).

Details
Condition Ovarian Cancer Prevention
Treatment Placebo, Acetylsalicylic acid
Clinical Study IdentifierNCT03480776
SponsorCanadian Cancer Trials Group
Last Modified on27 October 2022

Eligibility

 Yes No Not Sure

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
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