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

ConditionHead and Neck Squamous Cell Carcinoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with primary site mucosal recurrence in addition to neck disease

Trial design

Design model

Single group

Treatments tested in this trial

HRQOL instruments
Other intervention
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 intervention
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.

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: Quality of life questionnairesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Proportion of patients that experience a complications

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

Time frame

within 90 days post operatively

Secondary outcomes

changes in HRQOL scores

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.

Time frame

1 year

Sponsors and contacts

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Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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