Buccal Fat Reconstruction for Tonsil Cancer

(BOLT Trial)

Overseen By Michael Xie, MD FRCSC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Disqualifiers: Prior head and neck cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding buccal fat reconstruction (using cheek fat to support healing) during surgery for tonsil cancer can reduce postoperative pain. Researchers aim to determine if this technique alleviates pain during rest and swallowing and its impact on pain medication use, complications, or feeding tube necessity. Participants will undergo surgery with or without this reconstruction and compare their experiences. This trial may suit individuals with early-stage tonsil cancer requiring transoral robotic surgery. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that buccal fat reconstruction is safe for tonsil cancer surgery?

Research has shown that using buccal fat (fat from the cheek) for reconstruction is generally safe. One study focused on using this fat to repair the inner lining of the mouth and found the procedure effective and well-tolerated, with few complications. This suggests it is a reliable method.

Although specific data on using buccal fat reconstruction for tonsil cancer is lacking, its success in other mouth areas is promising. This indicates it could be a safe option for this new use as well. Always discuss potential risks and benefits with the trial team to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about buccal fat reconstruction for tonsil cancer because it offers a new approach to reconstructing the mouth area after surgery. Unlike standard treatments like radiation or chemotherapy, which primarily aim to kill cancer cells, this technique focuses on improving the healing and function of the mouth following surgical removal of cancerous tissue. By using buccal fat, which is naturally found in the cheeks, this method could enhance recovery and maintain better oral function, potentially leading to improved quality of life for patients.

What evidence suggests that buccal fat reconstruction might be an effective treatment for reducing pain after transoral robotic surgery for tonsil cancer?

This trial will compare two surgical approaches for tonsil cancer: transoral lateral oropharyngectomy alone and transoral lateral oropharyngectomy with buccal fat reconstruction. Research has shown that buccal fat reconstruction can be beneficial in throat cancer surgery. One study found that using a buccal fat pad flap, along with a buccinator myomucosal flap, effectively covers areas in the throat after cancer removal. This method reliably heals areas affected by cancer surgery and helps fill gaps left by tissue removal, potentially reducing pain and improving swallowing post-surgery. This technique is a valuable option for patients undergoing throat cancer surgery. Overall, buccal fat reconstruction offers promising improvements for those recovering from tonsil cancer surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Christopher Yao, MD FRCSC

Principal Investigator

University Health Network, Toronto

John R de Almeida, MD MSc FRCSC

Principal Investigator

University Health Network, Toronto

Michael Xie, MD FRCSC

Principal Investigator

University Health Network, Toronto

Rosemary Martino, Ma MSc PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for patients with certain throat cancers, including oropharynx and tonsil cancer, who are undergoing transoral robotic surgery. Participants must be able to provide pain and swallowing assessments post-surgery. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am older than 18 years.

I need a specific throat surgery for early-stage tonsil cancer.

Ability to understand and willing to sign a written informed consent

Exclusion Criteria

I have swollen lymph nodes on both sides of my neck.

I need open surgery for my throat cancer.

Patients with trismus at baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo transoral robotic surgery with or without buccal fat reconstruction

Immediate postoperative period

In-hospital stay

Postoperative Monitoring

Participants' pain, swallowing, and other outcomes are assessed at multiple time points post-surgery

4 weeks

Postoperative day 1-3, 7-10, 21-28

Follow-up

Participants are monitored for surgical complications and other secondary outcomes

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Buccal Fat Reconstruction

Trial Overview The study is testing if using buccal fat (fat from the cheek) to reconstruct the surgical area after transoral robotic surgery can reduce pain compared to not using it. Pain levels during rest and swallowing will be measured, along with other factors like complications and medication usage.

How Is the Trial Designed?

Group I: Transoral lateral oropharyngectomy with buccal fat reconstruction Experimental Treatment 1 Intervention

Transoral lateral oropharyngectomy with buccal fat reconstruction

Group II: Transoral lateral oropharyngectomy alone Active Control 1 Intervention

Transoral lateral oropharyngectomy without buccal fat reconstruction

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3389788/

Outcomes of Salvage Surgery With Free Flap Reconstruction ... Median survival overall following salvage surgery was 44.8 months for oral cavity and 53.8 months for oropharynx head and neck squamous cell carcinoma. Overall ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4513054/

Lateral Oropharyngeal Wall Coverage with Buccinator ... A buccinator myomucosal flap with a buccal fat pad flap is a reliable and valuable option in the reconstruction of oropharyngeal defects after cancer resection.

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.857445/full

Flap Reconstruction of the Oropharyngeal Defect After ... The 3-year survival rate is 100%, and the 3-year recurrence-free survival rate is 84.58%. Conclusion: The surgical approach of combined ...

4. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/full/10.1002/ohn.1221

Functional Outcomes of Free Flap Reconstruction After TORS ... Small oropharyngeal tumors resected via TORS typically heal by secondary intention, whereas larger and more complex defects require free flap ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2780537

Association of Advanced-Stage Oropharyngeal Squamous ... This study provides comprehensive data on disease outcomes, failure patterns, and adjuvant treatment associated with different primary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12493023/

Oral Diet Outcomes and Tracheostomy Avoidance After ... The objective of this study is to describe functional outcomes after this reconstruction. Methods. Retrospective chart review was performed for ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/hed.21290

Complications and functional outcomes following complex ... Conclusions. Microvascular free flap and/or pectoralis pedicled flap reconstruction of extensive oropharyngeal defects is safe and reliable, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5968009/

Reconstruction of cheek mucosal defect with a buccal fat pad ... The size of the removed lesion with a safety margin was 2.1 × 2.0 × 0.9 cm (Fig. 2a), and the buccal mucosa defect was reconstructed as a ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798321004765

Functional outcomes of soft palate free flap reconstruction ... Swallowing outcomes were satisfactory, with mean overall DHI scores indicative of slight or no handicap in 82.8% of the patients. Patient quality of life was ...