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ASA in Prevention of Ovarian Cancer (STICs and STONEs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480776
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : December 19, 2022
Sponsor:
Collaborator:
Apotex Inc.
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Prevention Drug: Acetylsalicylic acid Other: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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)
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acetylsalicylic Acid (ASA) Drug: Acetylsalicylic acid
81 mg PO daily or 325 mg PO daily
Other Name: ASA
Sham Comparator: Placebo Other: Placebo
One tablet PO daily


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire [ Time Frame: 5 years ]
  2. Compliance of taking ASA by serum monitoring [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Compliance of taking ASA by evaluation of treatment completion rates [ Time Frame: 5 years ]
  2. Compliance of taking ASA by reasons for early discontinuation of protocol intervention. [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480776


Locations
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Sponsors and Collaborators
Canadian Cancer Trials Group
Apotex Inc.
Investigators
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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
More Information
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT03480776    
Other Study ID Numbers: OV25
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: December 19, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
 Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents