Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube

University of Oklahoma (OU)

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Fallopian Tube Infection

Fallopian Tube Cancer

Treatments

Drug: Aspirin 81 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03771651

9955

Details and patient eligibility

About

This study will evaluate the impact of low dose aspirin on normal fallopian tube fimbriae in women who have surgery to have their fallopian tubes removed. Participants will take a low dose of aspirin for 2 weeks before their surgery. A portion of the removed fallopian tubes will also be collected for future research and routine pathology purposes.

Full description

Subjects in this study will receive low dose aspirin for 14 days before undergoing surgery to remove fallopian tubes removed to determine whether aspirin decreases inflammation in the fallopian tube. Subjects will also submit blood samples at their initial visit with their oncologist, at the time of surgery and at the pre-operative visit to measure inflammation markers and blood counts. A portion of the subject's fallopian tube will be collected for future research studies.

Enrollment

18 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
Eligible women will have fulfilled their childbearing desires
Age > 21 Considered low risk for prevalent fallopian tube cancer (not undergoing risk reducing surgery for a known BRCA mutation or other known hereditary predisposition syndrome, family history of ovarian cancer in a first degree relative.

Exclusion criteria

Males
Women who have presumed or known gynecologic cancer
Women less than 21 years of age
Women currently on either regular aspirin therapy, non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen or chronic steroidal anti-inflammatory medications.
Women with known bleeding diathesis or bleeding disorder.
Women who do not consent for removal of both fallopian tubes.
Women with a history of gastritis or peptic ulcer disease requiring treatment. (Patients with a history of occasional H1 or H2 blocker use for gastro esophageal reflux disease are NOT excluded).
Women with reported aspirin or NSAID allergy
Women with asthma and/or nasal polyps