A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment

Study Overview
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Brief Summary
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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.

Official Title
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The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Other: HRQOL instruments
* Other: LENT SOMA instrument


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a descriptive, single-arm pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quality of life questionnaires<br>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. | Other: HRQOL instruments<br>* 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).<br>Other: LENT SOMA instrument<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that experience a complications | 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 | within 90 days post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in HRQOL scores | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Free fat flap, Reconstruction, Quality of life, 23-102