ASA for Ovarian Cancer Prevention

Recruiting at 17 trial locations

Overseen By Wendy Parulekar

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Canadian Cancer Trials Group

Must not be taking: PARP-inhibitors, Anti-coagulants

Disqualifiers: Other malignancies, Active bleeding, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

117 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anti-coagulants, anti-platelet agents, or have a history of chronic daily use of ASA or NSAIDs.

What data supports the effectiveness of the drug acetylsalicylic acid (aspirin) for ovarian cancer prevention?

Some studies suggest that long-term use of aspirin may help people with various cancers, including ovarian cancer, live longer. Additionally, frequent aspirin use has been linked to a lower risk of developing ovarian cancer. ^{1 2 3 4 5}

Is acetylsalicylic acid (aspirin) generally safe for humans?

Aspirin is one of the most widely used drugs globally and is generally considered safe for long-term use in humans, although it may have side effects like stomach irritation or bleeding, especially at higher doses. ^{2 3 5 6 7}

How is the drug acetylsalicylic acid (aspirin) unique in preventing ovarian cancer?

Acetylsalicylic acid (aspirin) is unique in preventing ovarian cancer because it is a non-steroidal anti-inflammatory drug (NSAID) that may reduce cancer risk by inhibiting processes that contribute to tumor growth and progression, unlike traditional cancer treatments that directly target cancer cells. ^{2 3 5 7 8}

What is the purpose of this trial?

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.

Research Team

Stephanie Lheureux

Principal Investigator

Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

Amit Oza

Principal Investigator

Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

Eligibility Criteria

This trial is for women over 18 with a high risk of ovarian cancer due to BRCA1/2 mutations, who plan to have preventive surgery within 6 months to 2 years. They must be in good health, not pregnant or breastfeeding, and not on blood thinners or anti-inflammatory drugs. Participants should agree to use effective contraception and complete questionnaires in English or French.

Inclusion Criteria

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

I plan to have surgery to lower my cancer risk within 6 months to 2 years after joining the study.

I am fully active or can carry out light work.

Exclusion Criteria

I had cancer before, but it was either skin cancer, cervical cancer treated without surgery, breast cancer treated to cure, or any cancer cured over 5 years ago.

You are allergic to aspirin or have a history of asthma caused by aspirin or similar drugs like ibuprofen.

Ongoing or planned pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Acetylsalicylic Acid (ASA) or placebo to assess its effectiveness in preventing ovarian cancer

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Acetylsalicylic acid
• Placebo

Trial Overview The study tests if Acetylsalicylic acid (ASA), an anti-inflammatory drug, can prevent ovarian cancer compared to a placebo. Women will be randomly assigned ASA or placebo before their scheduled risk-reducing surgery.

Participant Groups

Group I: Acetylsalicylic Acid (ASA) Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Apotex Inc.

Industry Sponsor

Trials

9

Recruited

29,000+

Findings from Research

In a study of 4,117 women with epithelial ovarian cancer, postdiagnosis use of low-dose aspirin showed no significant reduction in ovarian cancer-specific mortality, with a hazard ratio of 1.02.

The findings suggest that low-dose aspirin does not improve survival rates for ovarian cancer patients, as the hazard ratios remained neutral regardless of aspirin use patterns or other mortality predictors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin use and ovarian cancer mortality in a Danish nationwide cohort study. Verdoodt, F., Kjaer, SK., Dehlendorff, C., et al.[2019]

Aspirin (ASA) significantly inhibits the activity of myeloperoxidase (MPO), an enzyme elevated in women with ovarian cancer, with a concentration of 50 mM leading to over 90% inhibition.

This study suggests that aspirin may have a beneficial role in cancer treatment by affecting MPO activity, which could contribute to its potential survival benefits in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Acetylsalicylic Acid, as a Representative Non-Steroidal Anti-Inflammatory Drug, on the Activity of Myeloperoxidase. Gąsowska-Bajger, B., Sosnowska, K., Gąsowska-Bodnar, A., et al.[2023]

Observational studies suggest that long-term consistent use of aspirin may modestly reduce the risk of ovarian and endometrial cancer, particularly in certain subgroups like individuals with a high body mass index.

The evidence for non-aspirin NSAIDs is less clear, and there is a need for more research to better understand the impact of both aspirin and non-aspirin NSAIDs on cancer risk and prognosis, especially regarding factors like dosage and duration of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of aspirin and non-aspirin NSAID use on ovarian and endometrial cancer: Summary of epidemiologic evidence of cancer risk and prognosis. Verdoodt, F., Kjaer, SK., Friis, S.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Aspirin use and ovarian cancer mortality in a Danish nationwide cohort study. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Acetylsalicylic Acid Exerts Potent Antitumor and Antiangiogenic Effects in Cutaneous and Uveal Melanoma Cell Lines. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Association of Frequent Aspirin Use With Ovarian Cancer Risk According to Genetic Susceptibility. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Aspirin, nonaspirin nonsteroidal anti-inflammatory drugs, acetaminophen and ovarian cancer survival. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Acetylsalicylic Acid, as a Representative Non-Steroidal Anti-Inflammatory Drug, on the Activity of Myeloperoxidase. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Influence of aspirin and non-aspirin NSAID use on ovarian and endometrial cancer: Summary of epidemiologic evidence of cancer risk and prognosis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of nonsteroidal anti-inflammatory agents (NSAIDs) on ovarian carcinoma cell lines: preclinical evaluation of NSAIDs as chemopreventive agents. [2014]

8. Germany pubmed.ncbi.nlm.nih.gov

Paradoxical effect of aspirin on the growth of C6 rat glioma and on time of development of ENU-induced tumors of the nervous system. [2019]