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

September 6, 2022 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34329
        • Sarasota Memorial Healthcare System
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Khorana score = 1
  • Over age 18
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin
Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer.
Drug: Aspirin
81 mg aspirin daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing a Venous Thromboembolism
Time Frame: Up to six months
Up to six months
Number of Participants With at Least One Adverse Event
Time Frame: Up to six months
Adverse events will only include those that are determined to be related to the study drug.
Up to six months
Medication Adherence
Time Frame: Up to six months
Patient adherence to aspirin as defined by percent of pills used.
Up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Brittany Davidson, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2020

Primary Completion (Actual)

March 2, 2022

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00105081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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