Actively Recruiting
An Open-label Pilot Study to Evaluate Medication Satisfaction With Apixaban Versus Enoxaparin for Thrombosis Prevention After Head and Neck Cancer Surgery
Led by Kiranya Arnold · Updated on 2025-10-08
76
Participants Needed
1
Research Sites
13 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
Researchers are studying whether apixaban, a pill taken twice daily, is a safe and easier alternative to enoxaparin, a daily injection, for preventing blood clots after head and neck cancer surgery. The trial aims to find out if apixaban can be safely used instead of enoxaparin, how patients feel about taking each medicine, and how well patients follow their treatment plans. This is a Phase 4, open-label, randomized study comparing two treatments for clot prevention after surgery. Participants will be assigned to one of two groups: one group takes apixaban orally twice a day for 10 days starting 12 to 24 hours after surgery, while the other group receives enoxaparin as a daily injection for 10 days after surgery. Both treatments are aimed at preventing deep vein thrombosis (DVT). The study includes follow-up visits to monitor safety and treatment adherence. During the study, participants will keep a medication diary and return unused medicine to check adherence. They will complete short surveys about their satisfaction with the medication. An ultrasound of the legs will be performed 11 to 14 days after surgery to check for blood clots. Follow-up visits will occur around 40 and 80 days after surgery to assess safety. Overall participation lasts about four months from surgery through the last follow-up visit.
CONDITIONS
Brief Title
Apixaban or Enoxaparin After Head and Neck Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent.
- Be willing and able to comply with study procedures and follow-up.
- Be 18 to 89 years old, male or female.
- Have a negative pregnancy test within 24 hours before surgery if a woman of childbearing potential.
- Have biopsy-proven head and neck cancer or suspected cancer awaiting tissue diagnosis.
- Be scheduled for major inpatient or outpatient oncologic head and neck surgery lasting more than 45 minutes.
- Be an appropriate surgical candidate with adequate performance status.
- Eligible diagnoses include squamous cell carcinoma of oral cavity, hypopharynx, larynx, nasal cavity; malignancies from major salivary glands; non-melanoma skin cancers; unknown primary tumors of head and neck.
You will not qualify if you...
- Lack a tissue diagnosis of head and neck cancer during the study period.
- Have benign disease, primary thyroid cancer, lymphoma, or melanoma instead of eligible cancer.
- Fail to undergo definitive head and neck oncologic surgery.
- Have surgery limited to tissue diagnosis only.
- Be unable to administer the study drug yourself or with caregiver help.
- Have a positive pregnancy test on the day of surgery.
- Have a known history of prior deep vein thrombosis or pulmonary embolism.
- Have hereditary or acquired bleeding or clotting disorders.
- Have severe renal impairment with creatinine clearance below 30 mL/min.
- Have any conditions that make participation unsafe or confuse study results as judged by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 days
Participants receive either 40 mg subcutaneous enoxaparin once daily or 2.5 mg oral apixaban twice daily for thrombosis prevention after head and neck cancer surgery.
Daily medication administration for 10 days
Duration - 3 to 4 days
Participants are assessed for medication satisfaction 11 to 14 days after completing the 10-day anticoagulant prophylaxis.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
SUNY Upstate
Syracuse, New York, United States, 13210
Actively Recruiting
Research Team
L
Laine Abernathy, MS
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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