Actively Recruiting
Apixaban or Enoxaparin After Head and Neck Cancer Surgery
Led by Kiranya Arnold · Updated on 2025-10-08
76
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
K
Kiranya Arnold
Lead Sponsor
S
State University of New York - Upstate Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 also learn about side effects of both medicines. The main questions it aims to answer are: Can apixaban be used safely instead of enoxaparin to prevent blood clots after surgery? Do patients find apixaban easier or more satisfying to take than enoxaparin? How well do patients follow the treatment plan with each medicine? Researchers will compare 2 groups: One group will take apixaban (a pill taken twice a day) for 10 days after surgery. The other group will take enoxaparin (a shot given once a day) for 10 days after surgery. Participants will: Take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total Keep a medication diary and bring back unused medicine so the study team can check adherence Complete short surveys about satisfaction with their medicine Have an ultrasound of their legs to check for blood clots 11-14 days after surgery Return for follow-up visits about 40 days and 80 days after surgery for safety checks How long will participation last? About 4 months from surgery through the last follow-up visit.
CONDITIONS
Official Title
Apixaban or Enoxaparin After Head and Neck Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent provided
- Willing and able to comply with study procedures and follow-up
- Age between 18 and 89 years, male or female
- Negative pregnancy test within 24 hours before surgery if female of childbearing potential
- Biopsy-proven or suspected head and neck cancer awaiting diagnosis
- Scheduled for major inpatient or outpatient head and neck cancer surgery lasting more than 45 minutes
- Considered an appropriate surgical candidate with adequate performance status
- Eligible diagnoses include squamous cell carcinoma of oral cavity, hypopharynx, larynx, nasal cavity; malignancies of major salivary glands; non-melanoma skin cancers; unknown primary tumors of head and neck
You will not qualify if you...
- No tissue diagnosis of head and neck cancer during the study period
- Diagnosed with benign disease, primary thyroid cancer, lymphoma, or melanoma instead of eligible cancer
- Did not undergo definitive head and neck oncologic surgery (only diagnostic biopsy)
- Surgery limited to tissue diagnosis only (e.g., direct laryngoscopy, excisional lymph node biopsy)
- Unable (patient or caregiver) to administer the study drug
- Positive pregnancy test on the day of surgery
- History of prior deep vein thrombosis or pulmonary embolism
- Hereditary or acquired bleeding or clotting disorders
- Severe kidney impairment (creatinine clearance less than 30 mL/min)
- Conditions making study participation unsafe or confounding results, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
SUNY Upstate
Syracuse, New York, United States, 13210
Actively Recruiting
Research Team
L
Laine Abernathy, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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