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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Women undergoing gynecologic surgery that includes removal of their fallopian tubes. This may include sterilization procedures, hysterectomy or partial or full adnexectomy
  • Eligible women will have fulfilled their childbearing desires
  • Considered low risk for prevalent fallopian tube cancer

Exclusion Criteria

  • Women who have gynecologic cancer
  • Women currently on either regular (greater than two doses per week for more than half of the previous 12 weeks prior to enrollment) aspirin therapy, non-steroidal anti-inflammatory drugs (NSAIDS), Tylenol or chronic steroidal anti-inflammatory medications
  • Women undergoing salpingectomy for indication of ovarian cancer risk reduction. Defined as having a known/previously tested BRCA mutation or other known hereditary pre-disposition syndrome
  • 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)

Locations & Contacts

Oklahoma

Oklahoma City
Stephenson Cancer Center
Status: Active
Contact: Laura L. Holman
Phone: 405-271-8787
Email: Laura-L-Holman@ouhsc.edu

Trial Objectives and Outline

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 & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Stephenson Cancer Center

Principal Investigator
Laura L. Holman

Trial IDs

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