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

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized clinical trial is to determine the pain intensity during rest and swallowing in patients undergoing transoral robotic surgery for tonsil lesions with and without buccal fat reconstruction. The main question it aims to answer is: does buccal fat after transoral robotic surgery reduce pain after surgery? Additional questions to be explored include if there is a difference in swallowing, complication rates, pain medication usage, and feeding tube usage. Participants will be asked to rate their pain and swallowing on a visual analogue scale after surgery. The group will be compared compared to a control group that undergoes transoral robotic surgery without buccal fat reconstruction.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+