Aspirin for Fallopian Tube Cancer

Overseen By Ingrid Block, APRN

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Must be taking: Aspirin

Must not be taking: NSAIDs, Acetaminophen, Steroids

Disqualifiers: Gynecologic cancer, Bleeding disorders, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how low-dose aspirin affects normal tissue in the fallopian tubes of women undergoing surgery to remove these tubes. Participants will take a small dose of aspirin daily for two weeks before their surgery. The study targets women who are having their fallopian tubes removed for non-cancerous reasons and have completed their plans for having children. Women planning surgery like a hysterectomy or tubal removal, without a history of ovarian cancer in close family, may find this trial suitable. As an Early Phase 1 trial, this research aims to understand how low-dose aspirin works in the body, offering participants a chance to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking regular aspirin, NSAIDs (non-steroidal anti-inflammatory drugs), acetaminophen, or chronic steroidal anti-inflammatory medications. If you are on these medications, you would need to stop them to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that aspirin is usually safe for people to take. Studies have found that regular aspirin use can lower the risk of certain cancers, such as ovarian cancer. In one large study, only 3.1% of participants died from cancer over nearly five years, suggesting aspirin might help protect against cancer.

Aspirin is already approved for other uses, such as pain relief and heart health, and has been tested for safety in many people. However, side effects like stomach upset or bleeding can occur, especially with long-term use. In this trial, the dose is low (81 mg daily for 14 days), similar to what is often used for heart health, and is less likely to cause problems.

Overall, evidence suggests that low-dose aspirin is generally safe for short-term use in people without specific risks for aspirin-related issues. Always consult a healthcare provider about possible risks and benefits before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for fallopian tube cancer, which often include surgery and chemotherapy, aspirin stands out due to its potential anti-inflammatory and anti-cancer properties. Researchers are excited about aspirin because it is a well-known, readily available medication that could provide a simpler, less invasive option with fewer side effects. While most treatments take longer to show results, aspirin might demonstrate its benefits in just 14 days, offering a quicker impact before surgery.

What evidence suggests that aspirin might be an effective treatment for fallopian tube cancer?

Research has shown that aspirin might aid in treating cancer. Studies have linked aspirin use to longer survival and reduced spread of various cancer types. For instance, regular aspirin use has been associated with a 21% lower risk of ovarian cancer. In animal studies, aspirin reduced ovarian cancer growth by 50–90%. Although limited information exists on fallopian tube cancer, these findings suggest aspirin could benefit similar cancers. Participants in this trial will take 81mg aspirin tablets daily for 14 days before surgery to remove fallopian tubes, to evaluate its potential benefits. ^{1 3 5 6 7}

Who Is on the Research Team?

Laura L. Holman

Principal Investigator

Stephenson Cancer Center, University of Oklahoma Health Sciences Center

Are You a Good Fit for This Trial?

This trial is for women over 21 who are having surgery to remove their fallopian tubes and have completed childbearing. They should not be at high risk for fallopian tube cancer, nor have a history of gynecologic cancer, bleeding disorders, or regular use of NSAIDs or aspirin. Women with gastritis, peptic ulcers, aspirin allergies, asthma with nasal polyps are excluded.

Inclusion Criteria

I am having surgery for a non-cancerous gynecologic condition that includes removing my fallopian tubes.

I am over 21 and at low risk for fallopian tube cancer, with no family history of ovarian cancer or known genetic risks.

Eligible women will have fulfilled their childbearing desires

Exclusion Criteria

I am a woman under 21 years old.

I have been treated for gastritis or peptic ulcer disease.

I have or am suspected to have cancer in my reproductive organs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low dose aspirin for 14 days prior to surgery for removal of fallopian tubes

2 weeks

3 visits (in-person)

Surgery

Participants undergo surgery to have their fallopian tubes removed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin

Trial Overview The study tests the effects of taking low-dose aspirin (81 mg) daily for two weeks before surgery on the biological and immunological aspects of normal fallopian tube tissue. The tissues removed during surgery will be analyzed to assess these changes.

How Is the Trial Designed?

Group I: Aspirin Experimental Treatment 1 Intervention

Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

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 (ASA) significantly inhibits the growth of endometrial cancer cells (Ishikawa cells) in vitro, with growth inhibition ranging from 21% to 88% at concentrations of 1-5 mM over 96 hours.

The mechanism of action includes inducing apoptosis and reducing bcl-2 expression, with higher concentrations of ASA leading to increased apoptosis and a shift in the cell cycle from the resting phase to the S phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin effects on endometrial cancer cell growth. Arango, HA., Icely, S., Roberts, WS., et al.[2019]

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]

Citations

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

Aspirin and cancer: biological mechanisms and clinical ... Aspirin is associated with increases in survival and reductions in metastatic spread and vascular complications of different cancers.

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

Role of aspirin in cancer prevention According to a study, high-frequency aspirin use was associated with a 13 % reduction in overall ovarian cancer risk and a 7–21 % reduction in risk among women ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2775219

Aspirin Use and Cancer Incidence and Survival in the ... Aspirin use was not associated with reduced risk of breast, bladder, esophageal, gastric, pancreatic, or uterine cancers.

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. 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 ...

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

Frequent Aspirin Use and Ovarian Cancer Risk According ... The findings of this study suggest that frequent aspirin use may lower risk of ovarian cancer regardless of an individual's genetic susceptibility to ovarian ...

7. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376759&isReview=true

ANZCTR - Registration A trial to investigate if aspirin reduces the risk of developing ovarian cancer in high risk women with abnormalities in their BRCA1 or BRCA2 gene (or both).