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NCT05889091 | RECRUITING | Head and Neck Squamous Cell Carcinoma

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

Condition or disease

Head and Neck Squamous Cell Carcinoma

Intervention/treatment

HRQOL instruments

LENT SOMA instrument

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study
Actual Study Start Date : 2023-05-16
Estimated Primary Completion Date : 2026-05-16
Estimated Study Completion Date : 2026-05-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment

Location Details

NCT05889091

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Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065