NCT07189897 · Kiranya Arnold
Apixaban or Enoxaparin After Head and Neck Cancer Surgery
What this study 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.
View original scientific description
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.
Interventions
DRUG
Enoxaparin
For DVT prophylaxis
DRUG
Apixaban
For DVT prophylaxis
Primary outcome measures
Study enrollment rate.
Time frame: From study start until target enrollment is reached (up to 24 months).
Enrollment rate will be calculated as the number of participants enrolled, divided by the number of eligible participants, multiplied by 100%.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Syracuse, New York
Collaborators
State University of New York - Upstate Medical University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2025 · Source of record for eligibility and locations