- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889091
A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment
October 12, 2023 updated by: Memorial Sloan Kettering Cancer Center
The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Evan Matros, MD
- Phone Number: 646-608-8044
- Email: matrose@mskcc.org
Study Contact Backup
- Name: Jennifer Cracchiolo, MD
- Phone Number: 212-639-8420
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Contact:
- Evan Matros, MD
- Phone Number: 646-608-8044
-
Contact:
- Jennifer Cracchiolo, MD
- Phone Number: 212-639-8420
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 90 days post operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Evan Matros, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2023
Primary Completion (Estimated)
May 16, 2026
Study Completion (Estimated)
May 16, 2026
Study Registration Dates
First Submitted
May 17, 2023
First Submitted That Met QC Criteria
May 25, 2023
First Posted (Actual)
June 5, 2023
Study Record Updates
Last Update Posted (Actual)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 12, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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