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Trial Title:
Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life
NCT ID:
NCT06667427
Condition:
Cancer
Head and Neck Cancer
Conditions: Official terms:
Bell Palsy
Facial Paralysis
Paralysis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Nerve transfer techniques
Description:
Participants will undergo facial nerve reconstruction using nerve transfer techniques
Arm group label:
Control
Arm group label:
Surgery
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas M. D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Z-Hye Lee, MD
Phone:
713-563-4598
Email:
zlee@mdanderson.org
Investigator:
Last name:
Z-Hye Lee, MD
Email:
Principal Investigator
Start date:
April 1, 2025
Completion date:
August 1, 2028
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06667427
http://www.mdanderson.org
