ASA in Prevention of Ovarian Cancer (STICs and STONEs)

March 25, 2024 updated by: Canadian Cancer Trials Group

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Peter McCallum Cancer Institute
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • King Edward Memorial Hospital
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Subiaco
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Clinical Research Unit at Vancouver Coastal
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Dr. H. Bliss Murphy Cancer Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
      • Toronto, Ontario, Canada, M5S 1B2
        • Women's College Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM-Centre Hospitalier de l'Universite de Montreal
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est-de-I'lle-de-Montreal
      • Quebec City, Quebec, Canada, G1R 2J6
        • Hotel-Dieu de Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CIUSSS de l'Estrie - Centre hospitalier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Placebo
Other: Placebo
One tablet PO daily
Active Comparator: Acetylsalicylic Acid (ASA)
Drug: Acetylsalicylic acid
81 mg PO daily or 325 mg PO daily
Other Names:
  • ASA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire
Time Frame: 5 years
5 years
Compliance of taking ASA by serum monitoring
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Time Frame
Compliance of taking ASA by evaluation of treatment completion rates
Time Frame: 5 years
5 years
Compliance of taking ASA by reasons for early discontinuation of protocol intervention.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

Apotex Inc.

Investigators

  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2018

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OV25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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