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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Other: HRQOL instruments; Other: LENT SOMA instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT05889091

23-102

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Quality of life questionnaires

Experimental group

Description:

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.

Treatment:

Other: LENT SOMA instrument

Other: HRQOL instruments