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

Trial Summary

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 data supports the effectiveness of the Fat ALT Flap Procedure for head and neck cancer?

Research shows that the anterolateral thigh (ALT) flap is reliable and versatile for reconstructing head and neck areas after cancer surgery. It is effective in repairing large defects with minimal damage to the area where the tissue is taken from. ^{1 2 3 4 5}

Is the Fat Flap Reconstruction for Head and Neck Cancer safe?

The Anterolateral Thigh (ALT) flap, used in head and neck reconstruction, is generally considered safe with a high success rate of 95.8%. The most common issue at the donor site is a hypertrophic scar (a thickened scar) occurring in about 10.3% of patients, but overall, donor site problems are minimal. ^{6 7 8 9 10}

How is the Fat ALT Flap Procedure different from other treatments for head and neck cancer?

The Fat ALT Flap Procedure is unique because it uses tissue from the thigh to reconstruct areas in the head and neck after cancer surgery, offering a reliable and versatile option with minimal donor site issues. Unlike other methods, it can be tailored to include only fat and fascia (connective tissue), avoiding the bulkiness of skin and muscle, which is beneficial for certain reconstructions. ^{1 6 11 12 13}

What is the purpose of 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.

Research Team

Evan Matros, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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 have been diagnosed with head and neck cancer.

I need further surgery for cancer in my neck lymph nodes that has come back or didn't fully go away.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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 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 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]

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 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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evolution of the anterolateral thigh free flap. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Application of Thinned Anterolateral Thigh Flap for the Reconstruction of Head and Neck Defects. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Application of anterolateral thigh free flap to reconstruct head and neck soft tissue defects]. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Application of free anterolateral thigh flap in head and neck surgery]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Anterolateral thigh flaps for reconstruction of head and neck defects. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Reconstructive Indications of Anterolateral Thigh Free Flaps in Head and Neck Reconstruction. [2020]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Comprehensive analysis of the anterolateral thigh flap vascular anatomy. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Incidence of inadequate perforators and salvage options for the anterior lateral thigh free flap. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Adipofascial anterolateral thigh free flap in hypopharyngeal and oropharyngeal reconstruction. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[The anterolateral thigh flap: its versatility in oncological soft tissue reconstruction of the head and neck region]. [2021]

13. United States 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. [2022]