Apixaban or Enoxaparin for Head and Neck Cancer Surgery

Overseen By Laine Abernathy, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Kiranya Arnold

Disqualifiers: Thyroid cancer, Lymphoma, Melanoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 10 days

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether apixaban, a pill, can safely replace enoxaparin, a daily injection, to prevent blood clots after head and neck cancer surgery. Researchers aim to determine if apixaban is easier and more satisfying for patients to take and how well patients adhere to their treatment plans with each medication. Participants will take either apixaban or enoxaparin for 10 days post-surgery, and the trial will last about four months in total. This trial suits those with a confirmed or suspected head and neck cancer diagnosis who are scheduled for major cancer surgery. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for these treatments?

Research has shown that apixaban is generally well-tolerated. In earlier studies, only 1% of patients taking apixaban experienced major issues like severe bleeding, indicating it is usually safe for most people. Additionally, apixaban has approval for other uses, further supporting its safety for humans.

Studies have found enoxaparin to be an effective and safe method for preventing blood clots. However, it requires daily injections, which some people find less convenient than taking a pill.

Overall, both apixaban and enoxaparin have a good safety record, and most people use them without serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care, which typically involves enoxaparin given via subcutaneous injection, apixaban offers a convenient oral alternative for preventing deep vein thrombosis (DVT) after head and neck cancer surgery. Apixaban is unique because it is taken as a pill twice daily, which might improve patient adherence compared to injectable options. Additionally, researchers are excited about the potential for apixaban to offer comparable or improved efficacy and safety, thanks to its targeted direct inhibition of Factor Xa, a key player in the blood clotting process.

What evidence suggests that this trial's treatments could be effective for preventing blood clots after head and neck cancer surgery?

This trial will compare Apixaban and Enoxaparin for preventing blood clots after head and neck cancer surgery. Studies have shown that Apixaban, which participants in this trial may receive, effectively prevents blood clots after surgery. It is as safe as Enoxaparin, another treatment option in this trial, with similar chances of major bleeding. Apixaban is usually easier to take because it is a pill, while Enoxaparin requires an injection. This convenience might improve adherence to the treatment plan. The American Society of Clinical Oncology (ASCO) recommends Apixaban for cancer patients to prevent blood clots, noting its lower risk of bleeding compared to some other treatments. Overall, Apixaban is a promising option for preventing clots after surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 with confirmed or suspected head and neck cancer, scheduled for surgery lasting over 45 minutes. Candidates must be able to follow the study procedures and attend follow-up visits. Women of childbearing potential need a negative pregnancy test before surgery.

Inclusion Criteria

I have signed and agreed to the study's consent form.

I have cancer originating from the major salivary glands.

I have a type of skin cancer that is not melanoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total

10 days

Daily self-administration

Follow-up

Participants return for follow-up visits for safety checks and ultrasound to check for blood clots

Approximately 3 months

Visits at 11-14 days, 40 days, and 80 days after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban
• Enoxaparin

Trial Overview The trial is testing if apixaban (a pill taken twice daily) can safely replace enoxaparin (a daily injection) to prevent blood clots after head and neck cancer surgery. Participants will take their assigned medication for 10 days post-surgery, keep a diary, complete surveys, and undergo ultrasounds.

How Is the Trial Designed?

Group I: Experimental: Apixaban Experimental Treatment 1 Intervention

2.5 mg oral apixaban given twice daily for DVT prevention.

Group II: Control: Enoxaparin Active Control 1 Intervention

40 mg subcutaneous enoxaparin given once daily for DVT prevention.

Who Is Running the Clinical Trial?

Kiranya Arnold

Lead Sponsor

State University of New York - Upstate Medical University

Collaborator

Trials

176

Recruited

27,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07189897

Apixaban or Enoxaparin After Head and Neck Cancer ... Study Overview. The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2767672

Apixaban vs Enoxaparin for Postoperative Prophylaxis ... Primary outcomes demonstrated safety of apixaban prophylaxis compared with enoxaparin; both major bleeding events (0.5% vs 0.5%, respectively; P > ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40142619/

Safety and Efficacy of Direct Oral Anticoagulants Apixaban ... This study employed a network meta-analysis approach to comparatively assess the safety and efficacy of DOACS and LMWH in preventing VTE among ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622062754

A randomized phase II trial of apixaban for the prevention ... In this phase II trial, 12 weeks of apixaban appeared to be well tolerated and acceptable for the prevention of VTE in ambulatory subjects undergoing first‐line ...

5. cancernetwork.com cancernetwork.com/view/asco-guidelines-strongly-recommend-apixaban-for-vte-in-cancer

ASCO Guidelines Strongly Recommend Apixaban for VTE ... Findings from the phase 3 ADAM VTE trial indicate that apixaban yields lower rates of major bleeding compared with dalteparin as a ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2767675

Safety and Efficacy of Apixaban vs Enoxaparin for ... These findings suggest that oral apixaban may offer a safe alternative to subcutaneous enoxaparin that is easier and less painful for patients to take.

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1814468

Apixaban to Prevent Venous Thromboembolism in Patients ... Efficacy and Safety Outcomes​​ During the treatment period, the primary outcome occurred in 3 of 288 patients (1.0%) in the apixaban group and in ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S153878362201501X

Apixaban and dalteparin in active malignancy‐associated ... Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancer patients.