This clinical trial evaluates the safety and effectiveness of fat flap reconstruction to reduce neck injury following cancer treatment in patients with head and neck cancer that has come back in the cervical lymph nodes (recurrent). The standard approach to treat remaining disease in the lymph nodes is routine neck surgery with a reconstructive procedure that involves removing a piece of muscle and inserting it into the neck where tissue was removed. In this study, a different reconstructive procedure will be done, called a fat anterolateral thigh (ALT) flap procedure. During a fat ALT flap procedure, the doctor will remove a piece of fat from the leg and insert it into the neck where tissue was removed. Head and neck cancer patients who are treated with radiation therapy and surgery may experience medical problems (called morbidity) after treatment, including difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. The ALT flap procedure may reduce neck morbidity because it uses healthy fat tissue which may promote regrowth of neck tissue and restore the function of the neck better than other surgical options, such as muscle flaps taken from the chest. A fat flap procedure may be a safe and practical option to reduce morbidity caused by cancer treatment in people with head and neck cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05889091.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Evan Matros
Phone: 646-608-8044
PRIMARY OBJECTIVE:
I. Estimate the proportion of patients that experience at least one flap-related, donor site, or hospitalization-related complication within 90 days post-operatively.
SECONDARY OBJECTIVES:
I. Evaluate the quality of life of patients undergoing the intervention by measuring the following patient reported outcomes, clinician reported outcomes, and objective quality-of-life-related measures:
Ia. Patient reported outcomes (PROs):
Iai. Face Q (Appearance);
Iaii. Face Q (Eating & drinking);
Iaiii. Face Q (Swallowing);
Iaiv. Face Q (Saliva);
Iav. Neck Dissection Impairment Index;
Iavi. Long-term ENT-Subjective/Objective/Management/Analysis (Late Effects of Normal Tissue Task Force [LENT]-Subjective, Objective, Management, Analytic [SOMA]);
Ib. Clinician reported outcomes:
Ibi. Long-term ENT-Subjective/Objective/Management/Analysis (LENT-SOMA);
Ic. Objective quality-of-life-related measures:
Ici. Inter-incisor distance (trismus) (mm);
Icii. Neck range of motion (measured using a goniometer - degrees of flexion, extension, lateral flexion, and rotation to both sides);
Iciii. Modified barium swallow study - assessed using the 8-point Penetration Aspiration Scale.
II. Measure the following technical aspects related to intervention:
IIa. Donor site (e.g., ALT);
IIb. Flap pedicle (descending branch [br], transverse br);
IIc. Number of (No.) perforators;
IId. Flap dimensions (cm^2);
IIe. SPY (yes [Y]/no [N]);
IIf. Recipient vessels.
OUTLINE:
Patients undergo fat ALT flap reconstruction during salvage neck dissection on day 0 of the study. Patients may also undergo SPY fluorescence imaging at time of surgery as well as a modified barium swallow pre-operatively and at 12 months post-operatively.
After completion of study treatment, patients are followed up at 1 week, 5 weeks, 6 months, and 12 months post-operatively.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEvan Matros
