ASA for Ovarian Cancer Prevention

Not currently recruiting at 18 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if acetylsalicylic acid (ASA), commonly known as aspirin, can help prevent ovarian cancer. Researchers believe that ASA's ability to reduce inflammation might lower the risk of developing ovarian cancer, which can be linked to inflammation in the ovaries. Suitable participants are women with a known BRCA1/2 genetic mutation who plan to undergo preventive surgery to remove their ovaries or fallopian tubes and have not been using ASA daily. As a Phase 2 trial, this research focuses on measuring ASA's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aspirin, also known as acetylsalicylic acid (ASA), is generally safe for use. Studies have found that regular low-dose aspirin users have a significantly lower chance of developing ovarian cancer. Specifically, one study found that current low-dose aspirin users had a 23% lower risk compared to non-users.

The FDA has already approved aspirin for other uses, such as pain relief and heart attack prevention, indicating a well-understood safety profile. However, like any medication, aspirin can cause side effects. Common side effects include stomach upset and an increased risk of bleeding, particularly at higher doses.

Overall, existing research supports the safety of regular low-dose aspirin use, which is promising for its potential role in preventing ovarian cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Most treatments for ovarian cancer involve surgery, chemotherapy, or targeted therapy. But acetylsalicylic acid (ASA), commonly known as aspirin, is being explored as a potential preventive option. Researchers are excited about ASA because it might offer a simple, widely available, and low-cost means to reduce the risk of developing ovarian cancer. Unlike traditional treatments that focus on managing the disease after it appears, ASA is being investigated for its potential to prevent cancer in the first place, possibly due to its anti-inflammatory properties. This new approach could be a game-changer in stopping ovarian cancer before it starts.

What evidence suggests that acetylsalicylic acid might be an effective treatment for ovarian cancer prevention?

Research has shown that taking aspirin, which participants in this trial may receive as Acetylsalicylic Acid (ASA), may help lower the risk of ovarian cancer. One study found that aspirin use was linked to an 11% lower chance of developing ovarian cancer. A review of 17 studies supports the idea that regular aspirin use can reduce the risk, especially for those at high risk. Additionally, a large study involving over 750,000 women found that daily aspirin intake reduced the risk of ovarian cancer by 10%. These findings suggest that aspirin's ability to reduce inflammation might help prevent ovarian cancer. ^{1 2 4 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7543116/

The role of aspirin in the prevention of ovarian, endometrial ... Results showed a moderate inverse association of aspirin with ovarian cancer incidence, with an 11% (95% CI: 0.83–0.96) relative reduction in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S246829422500022X

Role of aspirin in cancer prevention The results of this case-control study suggest that frequent aspirin use may reduce the risk of non-mucinous ovarian cancer [21].

3. facingourrisk.org facingourrisk.org/XRAY/aspirin-to-prevent-ovarian-cancer

Frequent aspirin use may reduce the risk of ovarian cancer Aspirin may help lower the risk of ovarian cancer in people who have a high risk of the disease, according to a new analysis of 17 studies.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9470249/

Aspirin and cancer: biological mechanisms and clinical ... With an average follow-up of only 4.7 years, cancer-related deaths occurred in 3.1% of the ten thousand participants randomized to aspirin, and ...

5. cancertherapyadvisor.com cancertherapyadvisor.com/factsheets/aspirin-and-liver-ovarian-cancers/

Aspirin and Liver, Ovarian Cancers In another cohort study of 758,829 women, daily use of aspirin (≥6 per week) significantly decreased the risk of ovarian cancer by 10% compared ...

6. ascopost.com ascopost.com/news/july-2022/meta-analysis-examines-link-between-aspirin-use-and-ovarian-cancer-risk/

Meta-Analysis Examines Link Between Aspirin Use and ... According to the report, researchers, “Observed a 23% lower risk of ovarian cancer among current low-dose aspirin users compared with nonusers.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5136300/

Anti-tumor and Anti-angiogenic Effects of Aspirin-PC in ... Using in vivo model systems of ovarian cancer, we found that aspirin-PC significantly reduced ovarian cancer growth by 50–90% (depending on the ovarian cell ...