The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Neck morbidity after radiation therapy and surgery includes difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. In addition, the researchers will find out whether the study procedure is effective at reducing neck morbidity and improving quality of life after cancer treatment. The researchers will measure quality of life by having participants answer questionnaires.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients 18 years or older
• Diagnosed with HNSCC (e.g., oropharyngeal, hypo/laryngeal SCC)
• Primary treatment is with radiotherapy with or without chemotherapy
• Salvage neck dissection is subsequently indicated for persistent or recurrent, nonmucosal disease in cervical lymph nodes
• At the time of salvage neck dissection additional flap coverage is indicated to improve carotid coverage or replace missing skin
Locations
United States
New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Contact Information
Primary
Evan Matros, MD
matrose@mskcc.org
646-608-8044
Backup
Jennifer Cracchiolo, MD
212-639-8420
Time Frame
Start Date:2023-05-16
Estimated Completion Date:2026-05-16
Participants
Target number of participants:12
Treatments
Experimental: Quality of life questionnaires
After the Fat Flap Reconstruction at 6 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment with either the Head and Neck Surgery (HNS) or Plastic \& Reconstructing Surgery (PLA) care team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team. At 12 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment. Patients will be asked to complete inter-incisor distance measurement and barium swallow assessment, done by a member of the SLP team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team.