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Procedure

Fat Flap Reconstruction for Head and Neck Cancer

N/A

Recruiting

Led By Evan Matros, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will investigate if a fat flap procedure is an effective way to reduce neck morbidity after cancer treatment, and if it improves quality of life for patients. Questionnaires will be used to measure quality of life.

Who is the study for?

This trial is for adults over 18 with Head and Neck Squamous Cell Carcinoma (HNSCC), who have had radiotherapy, possibly with chemo, and now need further surgery to remove persistent or recurrent cancer in neck lymph nodes. Candidates should require a fat flap procedure to cover the carotid artery or replace skin.Check my eligibility

What is being tested?

The study tests if the fat ALT flap reconstruction can reduce complications like swallowing difficulties, pain, stiffness, swelling, or appearance changes after neck cancer treatment. It involves questionnaires assessing life quality post-treatment.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical surgical risks such as infection at the site of surgery, bleeding, scarring and issues related to general anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients that experience a complications

Secondary outcome measures

changes in HRQOL scores

Trial Design

1Treatment groups

Experimental Treatment

Group I: Quality of life questionnairesExperimental Treatment2 Interventions

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,886 Total Patients Enrolled

Evan Matros, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

352 Total Patients Enrolled

Media Library

Fat ALT Flap Procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05889091 — N/A

Head and Neck Squamous Cell Carcinoma Research Study Groups: Quality of life questionnaires

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Fat ALT Flap Procedure Highlights & Side Effects. Trial Name: NCT05889091 — N/A

Fat ALT Flap Procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05889091 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings to participate in this investigation?

"The research study is currently accepting volunteers, as seen on clinicaltrials.gov. It was first published in mid-May of 2023 and the information has been updated just a few days ago."

Answered by AI

What is the current enrolment capacity for this trial?

"Affirmative. Clinicaltrials.gov showcases this clinical trial's active recruitment status, which began on May 16th 2023 and was last updated on the 25th of same month. The study is seeking to enrol 12 patients at 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05889091.