Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction

University of Pittsburgh

Status: Not yet enrolling

Conditions: Head and Neck Cancer

Treatments: Procedure: Facial Vein Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT07694726

STUDY26010093

Details and patient eligibility

About

* The goal of this clinical trial is to learn if facial vein reconstruction after neck dissection works to reduce rates of lymphedema in adults getting surgical treatment for head and neck cancer.

This is a trial which aims to improve the rate of lymphedema for patients undergoing treatment for head and neck cancer. Our aim is to re-establish venous flow across the facial vein to improve lymphatic drainage after neck dissection.

• The investigators will also evaluate lymphatic flow before and after facial vein reconstruction to determine if there is evidence of lymphedema.

• The main questions this study aims to answer are:

  1. Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients?
  2. Determine if there are changes in lymphatic flow before and after facial vein reconstruction?

After the study is completed, the investigators will compare rates of lymphedema and quality of life in patients with facial vein preservation/reconstruction as compared to previous patients treated for head and neck cancer without facial vein reconstruction.

Participants will undergo the following:

1. Oncologic and reconstructive surgery as normal. No changes in cancer treatment will occur due to the study.
2. When necessary, participants will undergo facial vein reconstruction immediately after neck dissection
3. Visit the clinic once every 3 months for routine checkups and tests. This is typical for most patients treated for head and neck cancer including those not enrolled in the trial.
4. Fill out short questionnaires to help understand quality of life after head and neck cancer treatment
5. Undergo lymphography in the OR and at the 1-year mark in the office. This is a simple test performed without radiation exposure. It requires 3 very small skin injections to perform the test.

Enrollment: 37 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Ability to comply with the study protocol, including follow up visits and additional requirements for data collection
• Ability to provide informed consent
• Patients requiring unilateral or bilateral neck dissection. Patients must undergo at least three level neck dissection which must include level 1B
• Patients will undergo radiotherapy +/-chemotherapy after surgery for HNC. Patients will be required to have adjuvant therapy after surgery to have similar risk of development of lymphedema.
• No history of allergy to indocyanine green.

Exclusion criteria

• Shellfish Allergy
• Contraindication to surgery under general anesthesia
• Prior head and neck surgery, radiation, or chemotherapy for HNC
• Patients requiring sacrifice of the internal jugular vein or resection of neck skin for oncologic care
• Anticipated partial or total laryngectomy
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Facial Vein Reconstruction Group

Experimental group

Description:

When necessary, participants will get facial vein reconstruction immediately after neck dissection. Participants will also undergo lymphography before and after vein reconstruction. If the facial vein is intact, no intervention is needed, but the patient may still participate in the study.

Treatment:

Procedure: Facial Vein Reconstruction