Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jan 2025
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedStudy Start
First participant enrolled
January 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
March 11, 2026
March 1, 2026
1.5 years
October 29, 2024
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control
EXPERIMENTALParticipants will be identified and recruited during their visit to the Center of Reconstructive Surgery.
Surgery
EXPERIMENTALInterventions
Participants will undergo facial nerve reconstruction using nerve transfer techniques
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients known to be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Z-Hye Lee, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2024
First Posted
October 31, 2024
Study Start
January 13, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2028
Last Updated
March 11, 2026
Record last verified: 2026-03