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NCT Number: NCT06667427

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Z-Hye Lee, MD

CONTACT

[email protected]

713-563-4598

Z-Hye Lee, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerve transfer techniques

Procedure

Participants will undergo facial nerve reconstruction using nerve transfer techniques

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Z-Hye Lee, MD

CONTACT

[email protected]

713-563-4598

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 31, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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