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

NCT04352439CompletedPHASE4INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Duke University

Enrollment

Start Date

2020-08-08

Completion Date

2022-03-02

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Aspirin

Conditions

Venous ThromboembolismOvarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Number of Participants Experiencing a Venous Thromboembolism

Time frame: Up to six months

Number of Participants With at Least One Adverse Event

Adverse events will only include those that are determined to be related to the study drug.

Time frame: Up to six months

Medication Adherence

Patient adherence to aspirin as defined by percent of pills used.

Time frame: Up to six months

Locations

Sarasota Memorial HealthCare System, Sarasota, United States

Duke University Hospital, Durham, United States

Linked Papers

2020-02-12

Incidence of venous thromboembolism among patients receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer

Neoadjuvant chemotherapy may be considered for women with epithelial ovarian cancer who have poor performance status or a disease burden not amenable to primary cytoreductive surgery. Overlap exists between indications for neoadjuvant chemotherapy and known risk factors for venous thromboembolism, including impaired mobility, increasing age, and advanced malignancy. The objective of this study was to determine the rate of venous thromboembolism among women receiving neoadjuvant chemotherapy for epithelial ovarian cancer. A multi-institutional, observational study of patients receiving neoadjuvant chemotherapy for primary epithelial ovarian, fallopian tube, or peritoneal cancer was conducted. Primary outcome was rate of venous thromboembolism during neoadjuvant chemotherapy. Secondary outcomes included rates of venous thromboembolism at other stages of treatment (diagnosis, following interval debulking surgery, during adjuvant chemotherapy, or during treatment for recurrence) and associations between occurrence of venous thromboembolism during neoadjuvant chemotherapy, subject characteristics, and interval debulking outcomes. Venous thromboembolism was defined as deep vein thrombosis in the upper or lower extremities or in association with peripherally inserted central catheters or ports, pulmonary embolism, or concurrent deep vein thrombosis and pulmonary embolism. Both symptomatic and asymptomatic venous thromboembolism were reported. A total of 230 patients receiving neoadjuvant chemotherapy were included; 63 (27%) patients overall experienced a venous thromboembolism. The primary outcome of venous thromboembolism during neoadjuvant chemotherapy occurred in 16 (7.7%) patients. Of the remaining venous thromboembolism events, 22 were at diagnosis (9.6%), six post-operatively (3%), five during adjuvant chemotherapy (3%), and 14 during treatment for recurrence (12%). Patients experiencing a venous thromboembolism during neoadjuvant chemotherapy had a longer mean time to interval debulking and were less likely to undergo optimal cytoreduction (50% vs 80.2%, p=0.02). Patients with advanced ovarian cancer are at high risk for venous thromboembolism while receiving neoadjuvant chemotherapy. Consideration of thromboprophylaxis may be warranted.

Linked Investigators

Julia Rose Salinaro