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

NCT ID: NCT05889091

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2026-05-16

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quality of life questionnaires

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.

Group Type: EXPERIMENTAL

HRQOL instruments

Intervention Type: OTHER

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).

LENT SOMA instrument

Intervention Type: OTHER

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.

Interventions

HRQOL 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).

Intervention Type: OTHER

LENT 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Matros, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evan Matros, MD

Role: CONTACT

matrose@mskcc.org

646-608-8044

Jennifer Cracchiolo, MD

Role: CONTACT

212-639-8420

Facility Contacts

Evan Matros, MD

Role: primary

646-608-8044

Jennifer Cracchiolo, MD

Role: backup

212-639-8420

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

23-102

Identifier Type: -

Identifier Source: org_study_id