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

Not Applicable

Recruiting

• Conditions: Cancer; Head and Neck Cancer

• Registration Number: NCT06667427
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Study Start: 2025-04-01
• Primary Completion: 2026-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Adverse Events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

The University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States