What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as chemotherapy agents like cyclophosphamide and anti-inflammatory drugs like celecoxib, can have various side effects. Cyclophosphamide is associated with side effects such as nausea, vomiting, hair loss, and increased risk of infection due to bone marrow suppression. Celecoxib, a COX-2 inhibitor, can cause gastrointestinal issues, cardiovascular risks, and renal side effects. Low-dose aspirin, used for its anti-inflammatory and antiplatelet effects, may lead to gastrointestinal bleeding, peptic ulcers, and increased risk of bleeding. These side effects should be carefully considered and monitored during treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of ovarian cancer, including chemotherapeutic agents like carboplatin and paclitaxel, which are often used in combination. Additionally, targeted therapies such as PARP inhibitors (e.g., olaparib, niraparib, and rucaparib) have been approved for patients with specific genetic mutations. While low-dose aspirin is being studied for its anti-inflammatory and antiplatelet effects, it is not yet a standard treatment for ovarian cancer. Current treatments focus more on chemotherapy, targeted therapy, and immunotherapy options.

What other types of research exist?

The provided context does not mention specific novel alternatives to low-dose aspirin for ovarian cancer patients. However, ongoing research and trials in the broader field of anti-inflammatory and antiplatelet therapies, such as selective COX-2 inhibitors and other NSAIDs, may offer potential alternatives. Patients should discuss with their healthcare provider to explore the most current and suitable options available in 2024.

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Aspirin for Fallopian Tube Cancer

Phase < 1

Waitlist Available

Led By Laura Holman

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women undergoing gynecologic surgery for presumed benign indications that includes the removal of their fallopian tubes. This may include sterilization procedures, hysterectomy or partial or full adnexectomy.

Be older than 18 years old

Must not have

Women less than 21 years of age

Women who have presumed or known gynecologic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from low-dose aspirin may include increased risk of bleeding, gastrointestinal issues like stomach pain or heartburn, allergic reactions in those sensitive to NSAIDs or aspirin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a woman under 21 years old.

Select...

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

Select...

I am a woman with asthma or nasal polyps.

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I am male.

Select...

I am allergic to aspirin or NSAIDs.

Select...

I do not agree to have both my fallopian tubes removed.

Select...

I have a known bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects who exhibited alterations in the fallopian tube immune microenvironment

Number of subjects who exhibited changes in transcriptome profile compared to control specimens

Number of subjects who exhibited less carcinogenic potential than control specimens

Side effects data

From 2011 Phase 2 & 3 trial • 93 Patients • NCT01586975

Nose bleeds

GI bleeding

Clinical Stroke

100%

80%

60%

40%

20%

Study treatment Arm

Aspirin 81 mg

Aspirin >300 mg

Clopidogrel 75 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AspirinExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin 81 mg

2019

Completed Phase 4

~1070

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include surgery, chemotherapy, and targeted therapies. Surgery aims to remove as much of the tumor as possible, while chemotherapy uses cytotoxic drugs to kill cancer cells or stop them from dividing. Targeted therapies, such as PARP inhibitors, focus on specific molecular targets associated with cancer. Low-dose aspirin, which is being studied for its anti-inflammatory and antiplatelet effects, may help by reducing inflammation and preventing blood clots, potentially improving drug delivery to residual tumor cells and enhancing overall treatment efficacy. This matters for ovarian cancer patients as it could lead to better management of the disease and improved outcomes.

The Role of Eicosanoids in Gynecological Malignancies.Use of anti-thrombotic agents during chemotherapy for epithelial ovarian cancer.