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NCT Number: NCT05889091

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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Location status: Recruiting

Location contact

Evan Matros, MD

CONTACT

646-608-8044

Jennifer Cracchiolo, MD

CONTACT

212-639-8420

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRQOL instruments

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

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.

Primary outcomes

  1. Proportion of patients that experience a complications

    Time frame: within 90 days post operatively

    Flap-related surgical complications - subjective and objective outcomes using validated instruments and CTCAE V5.0 i. Partial/total flap loss ii. Venous/arterial thrombosis iii. Infection iv. Hematoma v. Seroma Donor site i. Hematoma ii. Infection iii. Seroma iv. Dehiscence

Secondary outcomes

  1. changes in HRQOL scores

    Time frame: 1 year

    Appearance scores in HNSCC patients is +/- 18.1 if a similar standard deviation is observed. For the Face-Q Eating & Drinking, the standard deviation is 22, corresponding to a half width of +/- 12.4. For the Face-Q Swallowing, the standard deviation is 26, corresponding to a half width of +/- 14.7. For the Face-Q Saliva, the standard deviation is 27, corresponding to a half width of +/- 15.3. Due to the small sample size of this study, examination of the HRQOL scores will be exploratory and hypothesis generating in nature.

Study contacts

Contact information is provided by the study sponsor or research team.

Evan Matros, MD

CONTACT

[email protected]

646-608-8044

Jennifer Cracchiolo, MD

CONTACT

212-639-8420

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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