Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Free fat flap, Reconstruction, Quality of life, 23-102
Brief 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.
Interventions
OTHERHRQOL instruments
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).
OTHERLENT SOMA instrument
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a descriptive, single-arm pilot study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that experience a complications | within 90 days post operatively | Flap-related surgical complications - subjective and objective outcomes using validated instruments and CTCAE V5.0 i. Partial/total flap loss ii. Venous/arterial thrombosis iii. Infection iv. Hematoma v. Seroma Donor site i. Hematoma ii. Infection iii. Seroma iv. Dehiscence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in HRQOL scores | 1 year | Appearance scores in HNSCC patients is +/- 18.1 if a similar standard deviation is observed. For the Face-Q Eating \& Drinking, the standard deviation is 22, corresponding to a half width of +/- 12.4. For the Face-Q Swallowing, the standard deviation is 26, corresponding to a half width of +/- 14.7. For the Face-Q Saliva, the standard deviation is 27, corresponding to a half width of +/- 15.3. Due to the small sample size of this study, examination of the HRQOL scores will be exploratory and hypothesis generating in nature. |
Countries
United States
Contacts
CONTACTEvan Matros, MD
CONTACTJennifer Cracchiolo, MD
PRINCIPAL_INVESTIGATOREvan Matros, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed