Aspirin for Ovarian Cancer

Recruiting at 3 trial locations

Overseen By Tiffany Shiles

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: Neoadjuvant chemotherapy

Must not be taking: Chronic steroids, NSAIDs

Disqualifiers: Vascular events, Uncontrolled HTN, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking aspirin alongside chemotherapy can reduce markers linked to immune suppression in tumors for women diagnosed with certain types of ovarian, fallopian tube, or peritoneal cancer. Participants will randomly receive either aspirin or a placebo (inactive pill) during their treatment. Women recently diagnosed with these cancers, planning to start specific chemotherapy, and able to swallow pills might be suitable candidates. The goal is to determine if aspirin can enhance cancer treatment effectiveness by altering the tumor's immune environment. As an Early Phase 1 trial, this research focuses on understanding how aspirin works in people, offering participants a chance to contribute to pioneering cancer treatment studies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using anti-coagulation medication, you may need to temporarily stop based on your doctor's judgment.

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

Research has shown that aspirin is generally safe for most people. Studies with large groups have found that regular aspirin use might lower the risk of ovarian cancer and could help those already diagnosed live longer. For instance, one study found that daily aspirin use reduced the risk of ovarian cancer by about 10%.

While aspirin is widely used and safe for many, it can cause side effects, especially in higher doses. Some people might experience stomach upset or bleeding problems. However, these risks are usually low with the standard 325mg dose used in this trial. Prospective trial participants should consult their doctor, especially if they have a history of bleeding or stomach issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy and targeted therapy options for ovarian cancer, which can often be harsh and have significant side effects, aspirin is being investigated as a potential treatment due to its anti-inflammatory properties. Researchers are excited about aspirin because it is a well-known, widely available drug with a long history of safe use at low cost. Aspirin works differently by potentially reducing inflammation and hindering cancer cell growth, which could offer a gentler alternative or complement to existing treatments.

What evidence suggests that aspirin could be an effective treatment for ovarian cancer?

Research shows that aspirin might help fight ovarian cancer. In animal studies, aspirin reduced the growth of ovarian cancer by 50–90%. A study in Norway found that taking low-dose aspirin after an ovarian cancer diagnosis could extend survival. Another large study found that regular aspirin use lowered the risk of developing ovarian cancer by 10%. In this trial, participants will receive either a 325mg daily dose of aspirin or a placebo. These findings suggest that aspirin could be useful in managing ovarian cancer, and the current study aims to clarify its role in treatment. ^{3 4 5 6 7}

Who Is on the Research Team?

Jing-Yi Chern

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 18+ with ovarian, fallopian tube, or peritoneal carcinoma who haven't started treatment. They must be able to read English/Spanish (U.S.) or English/French (Canada), have a certain disease severity and type, plan to undergo specific chemotherapy followed by surgery, and meet health criteria like blood counts and organ function.

Inclusion Criteria

My liver function tests are within acceptable limits.

My kidneys work well enough, based on a creatinine clearance test.

I am set to receive specific chemotherapy before surgery for 3-5 cycles.

Exclusion Criteria

I cannot swallow pills and have stomach issues that could affect medication absorption.

I have not been diagnosed with any cancer other than non-melanoma skin cancer in the last 3 years.

I have severe esophagitis that hasn't improved with two treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aspirin or placebo with neoadjuvant chemotherapy

12 weeks

4 visits (in-person)

Interval Debulking Surgery

Participants undergo interval debulking surgery to assess changes in tumor markers

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Placebo

Trial Overview The study tests if aspirin can boost the immune system's response to tumors when given with standard chemo before surgery in patients with certain types of female reproductive cancers. Participants will either receive aspirin or a placebo alongside their chemotherapy regimen.

How Is the Trial Designed?

Group I: Participants Randomized to Aspirin Experimental Treatment 1 Intervention

Participants randomized to this arm will receive 325mg daily dose aspirin

Group II: Participants Randomized to Placebo Placebo Group 1 Intervention

Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Sharp

Industry Sponsor

Trials

4

Recruited

450+

Sharp Clinical Services, Inc

Collaborator

Trials

1

Recruited

100+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Aspirin not only reduces inflammation by blocking COX-2 in platelets but also has a direct antitumor effect on intestinal cells, potentially preventing cancer development, as shown in randomized trials involving patients with colorectal neoplasia and Lynch syndrome.

Aspirin is effective in reducing the risk of cancer recurrence and metastasis, with ongoing studies exploring its long-term anticancer benefits, while also being established as a treatment for antiphospholipid syndrome and for cardiovascular disease prevention in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin in the 21st century-common mechanisms of disease and their modulation by aspirin: a report from the 2015 scientific conference of the international aspirin foundation, 28 August, London, UK. Smith, T., Hutchison, P., Schrör, K., et al.[2021]

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]

In a study of 77 patients with clear cell ovarian cancer, those who used aspirin showed significantly improved disease-free survival and overall survival compared to non-users, with a hazard ratio of 0.13 indicating a strong protective effect.

Aspirin use remained a significant positive prognostic factor even after adjusting for age, cancer stage, and treatment status, suggesting its potential role in enhancing survival outcomes in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin use correlates with survival in women with clear cell ovarian cancer. Wield, AM., Walsh, CS., Rimel, BJ., et al.[2020]

Aspirin effectively reduces the growth of ovarian cancer cells that express high levels of COX-1, demonstrating a dose-dependent inhibition of cell viability when stimulated by EGF.

The mechanism of action involves aspirin blocking the phosphorylation of key proteins (Akt and Erk) that promote cell proliferation, suggesting that aspirin could enhance the effectiveness of treatments for COX-1 positive ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin Blocks EGF-stimulated Cell Viability in a COX-1 Dependent Manner in Ovarian Cancer Cells. Cho, M., Kabir, SM., Dong, Y., et al.[2021]

Aspirin-PC, a novel form of aspirin, was found to be significantly more effective than regular aspirin in inhibiting the growth of ovarian cancer cells in both human and mouse models, reducing tumor growth by 50% to 90%.

The combination of aspirin-PC with VEGF inhibitors like Bevacizumab enhanced its efficacy, while both aspirin formulations showed no gastrointestinal toxicity, making aspirin-PC a safer alternative for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor and Antiangiogenic Effects of Aspirin-PC in Ovarian Cancer. Huang, Y., Lichtenberger, LM., Taylor, M., et al.[2020]

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]

A nationwide case-control study involving 4,103 ovarian cancer cases and 58,706 controls found that low-dose aspirin use is associated with a reduced risk of epithelial ovarian cancer, with an odds ratio of 0.94 for ever use.

Long-term use of low-dose aspirin (≥5 years) showed an even greater reduction in risk (OR = 0.77), and continuous long-term use was linked to a significant decrease in risk (OR = 0.56), particularly for mucinous and endometrioid tumor types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose aspirin use and the risk of ovarian cancer in Denmark. Baandrup, L., Kjaer, SK., Olsen, JH., et al.[2022]

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]

Citations

1. 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 ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801817

Frequent Aspirin Use and Ovarian Cancer Risk According ... This case-control study pools and analyzes individual-level data from 8 Ovarian Cancer Association Consortium case-control studies to ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14168-y

a registry-based cohort study in Norway | BMC Cancer This study provides further evidence of a potential beneficial effect of post-diagnosis low-dose aspirin use for ovarian cancer survival.

4. 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 ...

5. 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].

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9958519/

Association of Frequent Aspirin Use With Ovarian Cancer ... The findings of this study suggest that frequent aspirin use may lower risk of ovarian cancer regardless of an individual's genetic ...

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

The role of aspirin in the prevention of ovarian, endometrial ... The most recent meta-analysis of the effect of aspirin use on the risk of ovarian cancer analysed 22 studies including more than 15,000 ovarian ...