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

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    150
  • sponsor
    Duke University
Updated on 25 January 2021
aspirin
cancer
thrombocytopenia
cancer chemotherapy
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 thromboembolic events among women with advanced ovarian cancer receiving neoadjuvant chemotherapy.

Subjects who are receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer 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. Subjects will be followed throughout the primary treatment course and monitored for the occurrence of venous thromboembolic events. Subjects will also be instructed to complete medication adherence diaries that will be reviewed by the research team. The investigators hypothesize that daily low dose aspirin will reduce the incidence of venous thromboembolic events during neoadjuvant chemotherapy when compared to a historical control.

The incidence of venous thromboembolism among the study cohort will be calculated with an estimated 95% exact binomial confidence interval. A drop of greater than 20% (from 8% estimated in the historical control to 6.4%) in rate of venous thromboembolism would be considered clinically meaningful. The investigators will also monitor for adverse drug 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 prophylaxis following some orthopedic procedures. The investigators therefore feel the potential benefit outweighs any clinically significant risks.

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 on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Venous Thromboembolism or Thromboembolism or Recurrent Ovarian Cancer or Ovarian Cancer or Ovarian Function or Ovarian disorder?
Do you have any of these conditions: ovarian tumors or Ovarian Cancer or Recurrent Ovarian Cancer or Thromboembolism or cancer of the ovary or Venous Thromboembolism or cancer, ovarian or...?
Over age 18
English-speaking female patients
Able to consent
Recruited from the Duke Gynecology Oncology clinic
Receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer

Exclusion Criteria

Allergy or intolerance to study medication
Indication for a specific form of antiplatelet (i.e. cardiac stent)
Already on anticoagulation
Active bleeding
High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal bleed)
Thrombocytopenia
Unable to complete medication adherence diary
Unable to take oral medications
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