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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Head and Neck Cancer
• Intervention / Treatment: Procedure: Nerve transfer techniques

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Z-Hye Lee, MD; Phone Number: 713-563-4598; Email: zlee@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas M. D. Anderson Cancer Center
      • Contact: Z-Hye Lee, MD; Phone Number: 713-563-4598; Email: zlee@mdanderson.org
      • Principal Investigator: Z-Hye Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 20 years

Exclusion Criteria:

Patients known to be pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery	Procedure: Nerve transfer techniques; Participants will undergo facial nerve reconstruction using nerve transfer techniques
Experimental: Control; Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery.	Procedure: Nerve transfer techniques; Participants will undergo facial nerve reconstruction using nerve transfer techniques

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Z-Hye Lee, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2024-1315; NCI-2024-09091 (Other Identifier: NCI-CTRP Clinical Trials Registray)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No