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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05889091
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Jun 2026
Primary completion
May 16, 2027
Completion
May 16, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Evan Matros, MD
646-608-8044
Jennifer Cracchiolo, MD
212-639-8420

Find similar trials in New York, NY

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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