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

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test if taking a small amount of aspirin daily can reduce inflammation in women who are having their fallopian tubes removed.

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 aspirin generally safe for humans?

Aspirin (also known as acetylsalicylic acid or ASA) is widely used and generally considered safe for humans, especially for long-term use in preventing heart attacks and strokes. However, it can cause side effects like stomach upset or bleeding, so it's important to use it under medical supervision. ^{1 2 3 4 5}

How does aspirin differ from other drugs for fallopian tube cancer?

Aspirin is unique because it is a common anti-inflammatory drug that may help improve survival in various cancers, including ovarian cancer, by inhibiting tumor growth and progression. Unlike traditional cancer treatments, aspirin is widely used for other conditions and may offer a novel approach to managing fallopian tube cancer. ^{1 2 3 6 7}

What evidence supports the effectiveness of aspirin as a drug for fallopian tube cancer?

Research suggests that aspirin may help improve survival in various cancers, including ovarian cancer, which is related to fallopian tube cancer. A study found that women with clear cell ovarian cancer who used aspirin had longer disease-free and overall survival compared to non-users. ^{1 2 3 6 8}

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 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]

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 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]

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]

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

Aspirin effects on endometrial cancer cell growth. [2019]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Aspirin use correlates with survival in women with clear cell ovarian cancer. [2020]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Characterization of the acetylation of cyclooxygenase-isozymes and targeted lipidomics of eicosanoids in serum and colon cancer cells by the new aspirin formulation IP1867B versus aspirin in vitro. [2023]

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

Acetylsalicylic Acid Exhibits Antitumor Effects in Esophageal Adenocarcinoma Cells In Vitro and In Vivo. [2018]