Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    60
  • sponsor
    Duke University
Updated on 16 August 2021
aspirin
cancer
thrombocytopenia
cancer chemotherapy
fallopian tube
angiogenesis inhibitor
venous thromboembolism
ovarian epithelial cancer
tumor debulking
ovarian epithelial carcinoma
cancer of the ovary
interval debulking surgery

Summary

This is a pilot study to determine the safety and efficacy of low dose aspirin for the prevention of venous thromboembolism among women with advanced ovarian cancer receiving neoadjuvant chemotherapy.

Description

Subjects who are receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer, including primaries of mullerian, peritoneal, or fallopian tube origin, with a Khorana score of 1 will be recruited from the Duke Gynecology Oncology clinic at Duke Cancer Institute. After discussion of the risks and benefits, written informed consent will be obtained for initiation of prophylactic, daily low dose aspirin (81 mg) therapy. Subjects will receive aspirin tablets in medication vials obtained from the Duke pharmacy supply and will be instructed to take one tablet daily until the day of their interval debulking surgery. The primary outcomes will be safety and medication adherence. Secondary outcome will be rate of VTE. We hypothesize that daily low dose aspirin will be safe with acceptable medication adherence and may reduce the incidence of venous thromboembolic events during neoadjuvant chemotherapy for low risk patients when compared to a historical control.

Adverse safety events and medication adherence will be evaluated using descriptive statistics using a validated questionnaire. We will calculate the incidence of venous thromboembolism among the study cohort and estimate a 95% exact binomial confidence interval. A drop greater than 20% (from 8% in the historical control to 6.4%) in the venous thromboembolism rate would be considered clinically meaningful. We will also monitor for adverse safety events related to low dose aspirin use, including major or minor bleeding events, clinically significant thrombocytopenia (resulting in treatment delay), and gastrointestinal complications. Of note, low dose aspirin for venous thromboembolism prevention is already considered an acceptable option for standard of care for patients with multiple myeloma receiving antiangiogenesis agents with chemotherapy and/or dexamethasone as well as for postoperative thromboprophylaxis for some orthopedic procedures; we therefore believe the potential benefit outweighs any clinically significant risks.

Subjects will be recruited from patients at the Duke Gynecology Oncology clinics at the Duke Cancer Center or Macon Pond (Duke Women's Cancer Care Raleigh) with advanced epithelial ovarian cancer, including primaries of mullerian, peritoneal, or fallopian tube origin, who are going to initiate neoadjuvant chemotherapy. A provider will approach the patient and inquire about interest in participating in the study. If the patient desires to receive more information about participating, clinical research personnel will discuss the study with patient and obtain informed consent if all selection criteria are met (detailed in a prior section). If the patient consents, they will then be considered an enrolled study subject. We will use the Duke hosted REDCap platform for collecting eConsent. If the patient is willing to hear about the study but a member of the research team is unable to be physically present in clinic, the research team will contact the patient via phone to perform the same recruitment, eligibility screening, and consent process that would typically be completed in person.

An estimated 120 patients will receive neoadjuvant chemotherapy for advanced ovarian cancer at Duke Gynecology Oncology clinics for the designated study recruitment period of 07/01/2020 to 12/30/2021 with an estimated 50% accrual rate for a total of 60 enrolled patients. Currently there is no established practice guideline for venous thromboembolism prophylaxis for these high risk patients. There will be no direct cost to subjects for participation in the study. They will not incur any costs for travel as they will already be presenting to Duke Gynecology Oncology clinic for their scheduled clinic visit. The study drug will be provided without cost. There will be additional time (10 minutes) incurred with study participation for informed consent and explanation of the study design and medication adherence diary. Subjects will not be compensated.

Details
Condition Ovarian disorder, Venous Thromboembolism, Ovarian Cancer, Thromboembolism, Ovarian Function, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment Aspirin
Clinical Study IdentifierNCT04352439
SponsorDuke University
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Over age 18
Khorana score = 1
English-speaking female patients
Able to consent
Receiving neoadjuvant chemotherapy Cancer of primary ovarian, fallopian tube, mullerian, or peritoneal origin

Exclusion Criteria

Allergy or intolerance to study medication
Indication for a non-aspirin form of antiplatelet (i.e. cardiac stent)
Already on alternative form of anticoagulation
Active bleeding
High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal bleed, known brain metastases)
Thrombocytopenia (platelets <50,000)
Unable to complete medication adherence diary
Unable to take oral medications
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