Fat Flap Reconstruction for Head and Neck Cancer

Overseen By Jennifer R. Cracchiolo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Primary site mucosal recurrence

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called the fat ALT flap (Anterolateral Thigh Flap) to determine if it can alleviate neck problems in individuals who have undergone head and neck cancer treatment. These issues may include trouble swallowing, pain, stiffness, swelling, or changes in appearance after radiation and surgery. Researchers aim to assess whether this procedure can enhance quality of life by reducing these problems. Individuals who have had head and neck cancer, primarily treated with radiation (with or without chemotherapy), and require additional surgery for non-mucosal disease in the neck, may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future patients' quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Fat ALT Flap Procedure is safe for reducing neck morbidity in HNSCC patients?

A previous study found that the Fat ALT Flap procedure had a complication rate of about 21%, meaning roughly 1 in 5 patients experienced issues. Despite this, the procedure is known for its stability, which is a positive aspect. Further research shows that it is generally safe and effective for treating problems in the head and neck area.

Since its introduction in 2008, doctors have gained experience with the procedure. While any surgery carries risks, many patients find the Fat ALT Flap procedure manageable. Results can vary, so discussing any concerns with your healthcare team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional reconstructive methods for head and neck cancer, which often rely on complex surgeries and synthetic materials, the Fat ALT Flap procedure uses the patient's own fat tissue for reconstruction. This approach is unique because it offers a more natural look and feel while potentially reducing the risk of rejection and complications associated with foreign materials. Researchers are excited about this technique as it also aims to improve patients' quality of life by potentially enhancing range of motion and functional outcomes, such as swallowing.

What evidence suggests that the Fat ALT Flap Procedure is effective for reducing neck morbidity in head and neck cancer patients?

Studies have shown that tissue from the upper thigh, known as the anterolateral thigh (ALT) flap, effectively and reliably rebuilds areas in the head and neck. It is stable and has a relatively low complication rate of about 21%. Research also suggests that the ALT flap is a strong choice for repairing damage from head and neck cancer treatments. Although some studies mention that radiation can affect the flap, it remains a top option for reducing long-term problems. This trial will evaluate the Fat ALT Flap Procedure, considered a practical way to improve patients' quality of life after cancer treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Evan Matros, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My main cancer treatment is radiation, possibly with chemo.

I need extra tissue to cover my neck area after surgery.

I have been diagnosed with head and neck cancer.

Exclusion Criteria

My cancer has returned in the mucosal area and has spread to my neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative Care

Participants undergo the fat ALT flap procedure and are monitored for immediate post-operative complications

90 days

Multiple visits for post-operative assessments

Follow-up

Participants are monitored for safety and effectiveness, including quality of life assessments and clinical evaluations

1 year

Assessments at 6 months and 12 months post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Fat ALT Flap Procedure

Trial Overview 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.

How Is the Trial Designed?

Group I: Quality of life questionnaires Experimental Treatment 2 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.

Fat ALT Flap Procedure is already approved in European Union, United States for the following indications:

Approved in European Union as Anterolateral Thigh Flap for:

• Head and neck reconstruction
• Soft tissue reconstruction

Approved in United States as ALT Flap for:

• Pharyngoesophageal reconstruction
• Oropharyngectomy reconstruction
• Head and neck cancer reconstruction

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The anterolateral thigh (ALT) free flap is a highly versatile option for reconstructing head and neck oncologic defects, allowing for the inclusion of various tissues like skin, muscle, and bone.

Recent advancements in harvesting techniques for the ALT free flap have expanded its applications, showing promising functional and aesthetic outcomes for complex reconstructions such as pharyngocutaneous and parotidectomy defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of the anterolateral thigh free flap. Graboyes, EM., Hornig, JD.[2022]

In a study of 1,547 ALT flaps and 57 AMT flaps used for head and neck cancer reconstruction, AMT flaps showed a significantly higher failure rate (15.0%) compared to ALT flaps (0.0%).

The AMT flap was more commonly used in patients with complex cases requiring reconstruction after cancer recurrence, indicating that while it can be a necessary option, it carries a greater risk of failure compared to the more reliable ALT flap.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the outcomes between free anteromedial thigh flap and anterolateral thigh flap in head and neck cancer reconstruction: Analysis of propensity-score-matched patient cohorts. Moltedo, NF., Wu, SC., Lin, CH., et al.[2022]

In a study of 43 patients who underwent reconstruction after head and neck cancer surgeries using free anterolateral thigh (ALT) flaps, the success rate was high at 93% (40 out of 43 cases), indicating the efficacy of this method for restoring function.

The ALT flaps not only effectively reconstructed defects but also preserved laryngeal function in 72.7% of patients with hypopharyngeal carcinoma, demonstrating their versatility and safety in complex surgical reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of free anterolateral thigh flap in head and neck surgery]. Liu, HW., Li, ZD., Dong, HL., et al.[2022]

The study analyzed 106 patients using CT angiograms to assess the anterolateral thigh (ALT) flap, revealing that perforator vessels were present in 88.8% of scans, with the most common type being hybrid musculoseptocutaneous vessels.

Significant differences in subcutaneous fat thickness were found between sexes, with males averaging 9.9 mm and females 19.9 mm, indicating that body composition can affect the utility of the ALT flap in reconstruction procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive analysis of the anterolateral thigh flap vascular anatomy. Seth, R., Manz, RM., Dahan, IJ., et al.[2012]

In a study involving 13 patients with buccal cancer and lower lip tumors, various types of anterolateral thigh (ALT) flaps were successfully used for reconstructing extensive head and neck defects, demonstrating the versatility of this technique.

All ALT flaps survived without major complications, and patients experienced significant improvements in mouth opening, with an average increase of 21.4 mm at one year post-surgery, indicating effective functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous reconstruction of head and neck defects following tumor resection and trismus release with a single anterolateral thigh donor site utilizing a lateral approach to flap harvest. Lin, PY., Chen, CC., Kuo, YR., et al.[2022]

In a study involving 20 patients, the free anterolateral thigh (ALT) flap demonstrated a high success rate of 95% for reconstructing soft tissue defects in the head and neck, indicating its efficacy as a reconstructive option.

The donor site morbidity was minimal, with most sites closed primarily, showcasing the ALT flap's advantages such as ease of closure and the ability to use large amounts of skin for reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterolateral thigh flaps for reconstruction of head and neck defects. Chen, CM., Chen, CH., Lai, CS., et al.[2022]

The ALT adipofascial flap, used in a study of 9 patients with hypopharyngeal and oropharyngeal carcinoma, demonstrated successful reconstruction outcomes with all patients resuming oral feeding within an average of 4.9 weeks post-surgery.

This flap is thinner than the traditional ALT flap, making it a suitable option for complex reconstructions, and it showed a low complication rate with an uneventful postoperative course in 8 out of 9 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipofascial anterolateral thigh free flap in hypopharyngeal and oropharyngeal reconstruction. Xu, F., Deng, D., Li, B., et al.[2022]

In a review of 1,079 planned anterolateral thigh (ALT) flaps for head and neck reconstruction, only 2.6% were discarded due to nonviable skin paddles or insufficient perforators, indicating that the ALT flap is generally reliable.

When issues with perforators were identified early, various salvage options were successfully employed, including anteromedial thigh and radial forearm flaps, with minimal additional morbidity for patients, demonstrating effective alternatives for reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of inadequate perforators and salvage options for the anterior lateral thigh free flap. Thomas, WW., Calcagno, HE., Azzi, J., et al.[2022]

The anterolateral thigh (ALT) free flap has a high success rate of 95.8% in reconstructive surgeries for head and neck defects, demonstrating its reliability and effectiveness over a 10-year study involving 194 flaps.

Donor site morbidity is minimal, with hypertrophic scars being the most common issue, affecting only 10.3% of patients, indicating that the ALT flap is a safe option for reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconstructive Indications of Anterolateral Thigh Free Flaps in Head and Neck Reconstruction. Khadakban, D., Kudpaje, A., Thankappan, K., et al.[2020]

The anterolateral thigh flap (ALT) was successfully used for soft tissue reconstruction in 33 patients with head and neck tumors, achieving satisfactory coverage without any flap losses.

The ALT offers several advantages, including a strong vascular supply, low donor site complications, and versatility in tissue composition, making it a reliable choice in reconstructive microsurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The anterolateral thigh flap: its versatility in oncological soft tissue reconstruction of the head and neck region]. Ensat, F., Schubert, H., Hladik, M., et al.[2021]

In a study of 43 patients, the thinned anterolateral thigh (ALT) flap demonstrated a high success rate for reconstructing head and neck defects, with 40 out of 43 flaps surviving completely and only 3 experiencing partial necrosis.

Patients reported high satisfaction with both the aesthetic and functional outcomes of the reconstruction, indicating that thinned ALT flaps are a viable option, especially for obese patients, due to their lower complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Thinned Anterolateral Thigh Flap for the Reconstruction of Head and Neck Defects. Gong, ZJ., Wang, K., Tan, HY., et al.[2022]

The anterolateral thigh (ALT) flap is a valuable option for reconstructing head and neck soft tissue defects, with a high success rate observed in a study of 20 patients, all of whom survived the procedure.

The ALT flap causes minimal damage to the donor site, allowing for primary suturing in most cases, which highlights its potential for effective and safe reconstruction in sensitive areas like the head and neck.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of anterolateral thigh free flap to reconstruct head and neck soft tissue defects]. Liu, WW., Liu, XK., Guo, ZM., et al.[2022]

Preoperative computed tomographic angiography (CTA) successfully identified and mapped perforators for anterolateral thigh (ALT) flaps in 32 patients, achieving a high accuracy rate of 98% in locating the branching origins of these vessels.

The use of CTA not only improved the identification of perforators but also contributed to a high flap survival rate of 97%, with no donor site morbidity, indicating its effectiveness and safety in head and neck cancer reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the perforators of anterolateral thigh flaps using 64-section multidetector computed tomographic angiography in head and neck cancer reconstruction. Chen, SY., Lin, WC., Deng, SC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12010011/

Adipofascial Anterolateral Thigh Free Flap in Head and ... Our series is the first to report the AF-ALT flap's efficacy in anterior skull base and orbital reconstructions, demonstrating an additional innovation in ...

2. scienceopen.com scienceopen.com/hosted-document?doi=10.18772/26180197.2025.v7n1a4

Efficacy of the Anterolateral Thigh Flap for Head and Neck ... This study confirms the advancement achieved with microvascular head and neck reconstruction, with anterolateral thigh flap as the workhorse flap.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11043495/

Reconstructive flap surgery in head and neck cancer patients These low-evidence studies suggest that radiotherapy accelerates flap atrophy, fibrosis, and osteoradionecrosis and deteriorates functional outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825001585

Application of Flap Economics in Head and Neck ... The anterolateral thigh (ALT) flaps showed the highest stability and lowest complication rate (21%), followed by radial forearm free flap (RFFF) ...

5. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2805361

Evaluation of Anterolateral Thigh Fascia Lata Rescue Flap The ALTFL procedure is a highly efficacious and low-morbidity option for the long-term management of mandibular osteoradionecrosis.

6. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02587-w

Facial reconstruction with thinned anterolateral thigh free flap Our study involved 117 patients, and we used 73 thinned ALT flaps to determine the best method to increase the flap's safety. After thinning, we ...