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NCT06667427 | NOT YET RECRUITING | Cancer

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

Condition or disease

Cancer

Head and Neck Cancer

Intervention/treatment

Nerve transfer techniques

Phase

NA

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
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2026-08-01
Estimated Study Completion Date : 2028-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life

Location Details

NCT06667427

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030