Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
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|ClinicalTrials.gov Identifier: NCT04352439|
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : August 25, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism Ovarian Cancer||Drug: Aspirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy|
|Actual Study Start Date :||August 8, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Patients receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer.
81 mg aspirin daily
- Rate of venous thromboembolism [ Time Frame: Up to six months ]Percentage of patients experiencing a venous thromboembolism.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352439
|Contact: Taylor Hayesfirstname.lastname@example.org|
|Contact: Bonnie Thieleemail@example.com|
|United States, North Carolina|
|Duke University Hospital||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Taylor Hayes|
|Principal Investigator:||Brittany Davidson, MD||Duke University|