Status:
RECRUITING
Apixaban or Enoxaparin After Head and Neck Cancer Surgery
Lead Sponsor:
Kiranya Arnold
Collaborating Sponsors:
State University of New York - Upstate Medical University
Conditions:
Venous Thromboembolism
Head and Neck Cancer
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will...
Eligibility Criteria
Inclusion
- Participants must:
- Provide signed and dated informed consent.
- Be willing and able to comply with study procedures and follow-up.
- Be 18-89 years old (male or female).
- Have a negative pregnancy test within 24 hours before surgery (if woman of childbearing potential).
- Have biopsy-proven head and neck cancer, or a suspected cancer awaiting tissue diagnosis (can be confirmed by frozen section at surgery).
- Be scheduled for major inpatient or outpatient oncologic head and neck surgery (defined as \>45 minutes operative time).
- Be an appropriate surgical candidate (adequate performance status).
- Eligible diagnoses include (not limited to):
- Squamous cell carcinoma of oral cavity, hypopharynx, larynx, nasal cavity
- Malignancies from major salivary glands
- Non-melanoma skin cancers (squamous cell, basal cell, Merkel cell carcinoma)
- Unknown primary tumors of head and neck
Exclusion
- Participants cannot:
- Lack a tissue diagnosis of head and neck cancer during the study period.
- Have one of these conditions instead of eligible cancer: Benign disease; Primary thyroid cancer (lower VTE risk); Lymphoma (not primarily surgical); or Melanoma
- Fail to undergo definitive head and neck oncologic surgery (e.g., only diagnostic biopsy).
- Have surgery limited to tissue diagnosis only (e.g., direct laryngoscopy, excisional lymph node biopsy).
- Be unable (patient or caregiver) to administer the study drug.
- Have a positive pregnancy test on the day of surgery.
- Have a known history of prior DVT or PE (since extended anticoagulation would be indicated).
- Have hereditary or acquired bleeding/clotting disorders.
- Have severe renal impairment (CrCl \<30 mL/min).
- Have conditions that, in the investigator's judgment, make study participation unsafe or confound results.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT07189897
Start Date
October 1 2025
End Date
December 1 2027
Last Update
October 8 2025
Active Locations (1)
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1
SUNY Upstate
Syracuse, New York, United States, 13210