Skip to main content

Low-Dose Aspirin in Decreasing Inflammation in Patients Undergoing Gynecologic Surgery

Trial Status: Active

This early phase I trial studies how well low-dose aspirin works in decreasing inflammation in patients undergoing gynecologic surgery that includes removal of their fallopian tube. Fallopian tube is a slender tube through which eggs pass from an ovary to the uterus. Low-dose aspirin may decrease inflammation in the fallopian tubes and may provide new information on ovarian cancer prevention that could benefit other patients in the future.

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 pre-disposition syndrome, family history of ovarian cancer in a first degree relative)

Exclusion Criteria

  • Women who have presumed or known gynecologic cancer
  • Women less than 21 years of age
  • Women who either in the last 12 weeks or are currently using regular (more than 1 dose per day for greater than 3 days of the week) 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

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Laura L. Holman
Phone: 405-271-8787

PRIMARY OBJECTIVES:

I. Compare immuno-molecular assays and percentages of specific immune cell types; such as M1 and M2 macrophages and tissue and serum cytokine expression such as IL-10 and TGF-beta in the aspirin treated fallopian tubes and blood compared to control tissue samples.

II. Compare the number of colony forming units in cultures of fallopian tube secretory epithelial cells and fallopian tube ciliated cells treated with a carcinogen in the aspirin and control group fallopian tube specimens.

III. To study the CCL2 gene single nucleotide polymorphism (SNP) in normal fallopian tube fimbria by comparing the percentages of specific immune cell types in fallopian tubes from women treated with aspirin with the AA, AT and TT rs1860190 genotypes.

OUTLINE:

Patients receive low-dose aspirin orally (PO) daily for 14 days in the absence of disease progression or unacceptable toxicity, prior to their scheduled fallopian tube surgery.

Trial Phase Phase O

Trial Type Treatment

Lead Organization
University of Oklahoma Health Sciences Center

Principal Investigator
Laura L. Holman

  • Primary ID OU201808LH
  • Secondary IDs NCI-2019-01624, 9955
  • Clinicaltrials.gov ID NCT03771651