ASA in Prevention of Ovarian Cancer (STICs and STONEs)

Ovarian Cancer Prevention Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03480776
• Other study ID #: OV25
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 24, 2018
• Est. completion date: September 15, 2025

Study information

• Verified date: March 2024
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: September 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer Prevention
• Ovarian Neoplasms

Intervention

Drug:
• Acetylsalicylic acid
81 mg PO daily or 325 mg PO daily

Other:
• Placebo
One tablet PO daily

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Peter McCallum Cancer Institute	Melbourne	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	King Edward Memorial Hospital	Subiaco	Western Australia
Australia	St John of God Subiaco	Subiaco	Western Australia
Australia	Westmead Hospital	Westmead	New South Wales
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	CHUM-Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	CIUSSS de l'Est-de-I'lle-de-Montreal	Montreal	Quebec
Canada	Hotel-Dieu de Quebec	Quebec City	Quebec
Canada	CIUSSS de l'Estrie - Centre hospitalier	Sherbrooke	Quebec
Canada	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	North York General Hospital	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario
Canada	Clinical Research Unit at Vancouver Coastal	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	Apotex Inc.

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance of taking ASA by evaluation of treatment completion rates		5 years
Other	Compliance of taking ASA by reasons for early discontinuation of protocol intervention.		5 years
Primary	Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test		5 years
Secondary	Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire		5 years
Secondary	Compliance of taking ASA by serum monitoring		5 years