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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-09091 | Other Identifier | NCI-CTRP Clinical Trials Registray |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery. |
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| Surgery | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve transfer techniques | Procedure | Participants will undergo facial nerve reconstruction using nerve transfer techniques |
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| 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 |
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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:
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:
Exclusion Criteria:
Patients known to be pregnant
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Z-Hye Lee, MD | Contact | 713-563-4598 | zlee@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Z-Hye Lee, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
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