Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Cancer; Head and Neck Cancer

Treatments: Procedure: Nerve transfer techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT06667427

NCI-2024-09091 (Other Identifier)

2024-1315

Details and patient eligibility

About

The goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.

Full description

Primary Objective:

To evaluate the impact of facial nerve transfer techniques (FNTT) on QoL in head and neck cancer patients with facial paralysis. This study intends to measure the impact of FNTT on QoL utilizing a series of validated questionnaires which include: (i) Facial Clinimetric Evaluation Scale and Facial Disability Index; (ii) Sunnybrook Facial Grading System; and (iii) Facial Nerve Grading Scale 2.0. These instruments will be administered at baseline, after surgery, and at 6, 12, and 18 months post-operatively.

Secondary Objective:

To compare patient-reported outcomes and facial function scales for patients who undergo facial nerve transfer technique with a historical cohort of patients who did not undergo any dynamic nerve reconstruction procedures. The same assessment tools described in primary objective above will be utilized.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in the intervention group of this study, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form
• Aged 18 or greater
• Patient scheduled to undergo facial nerve transfer
• Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

In order to be eligible to participate in the non-intervention historical control group of this study, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form
• Aged 18 or greater
• Previous facial surgery severing a facial nerve without graft or other form of dynamic facial nerve reconstruction within the last 5 years

Exclusion criteria

Patients known to be pregnant

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Control

Experimental group

Description:

Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery.

Treatment:

Procedure: Nerve transfer techniques

Surgery

Experimental group

Treatment:

Procedure: Nerve transfer techniques