Recruiting

Fat Flap Reconstruction

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05889091

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HRQOL instruments

LENT SOMA instrument

Study Details

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 ID

NCT05889091

Start date

May 16, 2023

Status verified date

Jun, 2026

Completion date

May 16, 2027

Anticipated

Primary completion date

May 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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).

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.

Primary outcome measure

  • Proportion of patients that experience a complications [ Time Frame: within 90 days post operatively ]

Central Contacts and Locations

Central contacts

Jennifer Cracchiolo, MD

212-639-8420

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Evan Matros, MD

646-608-8044

Jennifer Cracchiolo, MD

212-639-8420

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Free fat flap
  • Reconstruction
  • Quality of life
  • 23-102

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-03.