Cancer, Head and Neck Cancer
Conditions
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.
Interventions
PROCEDURENerve transfer techniques
Participants will undergo facial nerve reconstruction using nerve transfer techniques
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTZ-Hye Lee, MD
PRINCIPAL_INVESTIGATORZ-Hye Lee, MD
M.D. Anderson Cancer Center
Outcome results
None listed