RecruitingNot ApplicableNCT05889091

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

12 participants

Start Date

May 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether using a fat tissue flap during neck dissection surgery can reduce injury to major blood vessels and surrounding structures in head and neck cancer patients who need salvage surgery after radiation therapy. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with head and neck squamous cell carcinoma (such as throat or voice box cancer) - Your primary treatment was radiation therapy, with or without chemotherapy - You now need neck surgery because cancer persists or has come back in the lymph nodes - Your surgeon has determined that extra tissue coverage (a fat flap) is needed to protect the carotid artery or replace missing skin **You may NOT be eligible if...** - The cancer has also come back in the original tumor site (mouth/throat lining), not just the neck lymph nodes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHRQOL 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).

OTHERLENT 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.


Locations(1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

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NCT05889091


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