A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Other: HRQOL instrumentsOther: LENT SOMA instrument
- Registration Number
- NCT05889091
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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
- Patients with primary site mucosal recurrence in addition to neck disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Quality of life questionnaires LENT SOMA instrument 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. Quality of life questionnaires HRQOL instruments 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States