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Trial Title:
A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment
NCT ID:
NCT05889091
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Free fat flap
Reconstruction
Quality of life
23-102
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a descriptive, single-arm pilot study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
HRQOL instruments
Description:
These instruments include Face Q for Appearance, Eating & drinking, Swallowing, and
Saliva (patient-reported); the Neck Dissection Impairment Index (patient-reported); the
Long-term ENT-Subjective/Objective/Management/Analysis (LENT-SOMA) for skin-subcutaneous
tissue, muscle-soft tissue, mucosa - oral and pharyngeal, salivary gland, and mandible
(patient- and clinician-reported); modified barium swallow study (8-point penetration
aspiration scale).
Arm group label:
Quality of life questionnaires
Intervention type:
Other
Intervention name:
LENT SOMA instrument
Description:
LENT SOMA instrument will also be provided to summarize objective quality-of-life-related
measures recorded at 12 months postoperatively, including interincisor distance (mm);
neck range of motion measured in degrees of flexion, extension, lateral flexion, and
rotation to both sides; and shoulder range of motion, measured in degrees of abduction.
Arm group label:
Quality of life questionnaires
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with primary site mucosal recurrence in addition to neck disease
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Evan Matros, MD
Phone:
646-608-8044
Contact backup:
Last name:
Jennifer Cracchiolo, MD
Phone:
212-639-8420
Start date:
May 16, 2023
Completion date:
May 16, 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889091
http://www.mskcc.org/mskcc/html/44.cfm
