Tonsil NeoplasmPhase 2BOLTNCT06965738
Buccal Fat for Transoral Robotic Lateral Oropharyngectomy Defects to and Postoperative Pain
A Phase 2 study testing Buccal fat reconstruction and No buccal fat reconstruction in people with Tonsil Neoplasm and Oropharynx Neoplasm, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsil Neoplasm, Oropharynx Neoplasm, Transoral Robotic Surgery
- What is being tested?
- Buccal fat reconstruction and No buccal fat reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Require a transoral robotic lateral oropharyngectomy as a result of the following conditions :
- Early - intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/- SCC of the palatine tonsils)
- Early -intermediate stage salivary gland tumors of the palatine tonsils
- based on FNA, Core biopsy, Punch biopsy
- Ability to understand and willing to sign a written informed consent
Who cannot join
- History of prior head and neck squamous cell carcinoma, or prior head and neck radiotherapy
- Presence of retropharyngeal lymphadenopathy
- Presence of bilateral lymphadenopathy, or patients requiring bilateral neck dissections.
- Patients with trismus at baseline
- Patients with psychological risk factors for persistent opioid use or drug addiction
- Need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)
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.
Read the detailed description
Trans-oral robotic surgery (TORS) for oropharyngeal cancers have transformed how oropharyngeal cancers are managed, allowing for minimally invasive surgical access to remove tumors of the tonsil and base of tongue. While large incisions and open approaches can be avoided, oropharyngeal defects following TORS are traditionally left as an open wound to heal by secondary intention, resulting in significant postoperative pain, and possibly dysphagia and dehydration.
While this has been highlighted as a key outcome measure, studies on acute pain following TORS have not had any standardization regarding the timing of pain measurement, and pain assessment. Only one study has assessed pain during 'movement-related pain', such as swallowing, which has been advocated as a key metric. Most studies used a visual analogue scale, however, majority failed to describe the timing of pain assessment relative to administration of analgesia, time of day, or diet. Overall, pain ratings and opioid utilization were highly variable between studies resulting in pain ratings ranging widely from 2.5-8 in the first few days postoperatively.
Based on the current evidence, multimodal analgesia resulted in the lowest pain ratings following TORS, with those that included gabapentin, a COX-2 inhibitor and acetaminophen having excellent pain control in the early postoperative period. Using these regimens, Castellanos et al. found that postoperative opioid consumption significantly decreased in the first three postoperative days. Clayburgh, et al. identified that addition of perioperative corticosteroids was safe and significantly improved diet consistency, and decreased length of hospital stay, though pain scores were minimally affected.
No study thus far has assessed the impact of surgical interventions on postoperative pain and swallowing. This single center, phase II, randomized control trial aims to evaluate the impact of the buccal fat rotational flap on the postoperative pain following TORS.
- Being tested
- Buccal fat reconstruction, No buccal fat reconstruction
- Keywords
- Transoral Robotic Surgery, Buccal Fat, Postoperative Pain
- Medical subject headings
- Tonsillar Neoplasms, Oropharyngeal Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal fat reconstructionProcedure or surgery
Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect
No buccal fat reconstructionProcedure or surgery
No reconstruction of lateral oropharyngectomy defect
| Study group | Role | What they receive |
|---|---|---|
| Transoral lateral oropharyngectomy alone | Active comparator | Transoral lateral oropharyngectomy without buccal fat reconstruction Receives: Procedure: No buccal fat reconstruction |
| Transoral lateral oropharyngectomy with buccal fat reconstruction | Experimental | Transoral lateral oropharyngectomy with buccal fat reconstruction Receives: Procedure: Buccal fat reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain during rest and swallowing
Postoperative pain during rest and swallowing on visual analogue scale at multiple time points
Measured: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28
Secondary outcomes (7)
Surgical Complications
Surgical complications and adverse events within 30 days postoperatively using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC-AE v4.0)
Measured: 30 days postoperatively
Opioid usage
Determine opioid usage
Measured: 30 days postoperatively
Postoperative Hemorrhage
Postoperative hemorrhage after TORS
Measured: 30 days postoperatively
Speech and Swallowing
Determine postoperative speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN)
Measured: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Oral Diet
Determine food consistencies achieved at short post-operative follow up (per PSS-HN)
Measured: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Feeding Tube Placement
Determine rate of feeding tube placement
Measured: 30 days postoperatively
Blood Glucose
Determine blood glucose levels
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tonsil NeoplasmStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Yao, University Health Network, Toronto
- Investigators
- Christopher Yao, MD FRCSC, Principal investigator, University Health Network, TorontoJohn R de Almeida, MD MSc FRCSC, Study director, University Health Network, TorontoMichael Xie, MD FRCSC, Study chair, University Health Network, TorontoRosemary Martino, Ma MSc PhD, Study chair, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965738
- Sponsor's protocol ID
- 24-5894
- Acronym
- BOLT
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data, randomization, primary and secondary outcomes
Publications
Xie M, de Almeida J, Goldstein D, Martino R, Liu YF, Allen B, Xu W, Hueniken K, Yao CM. Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol. BMJ Open. 2025 Dec 12;15(12):e106125. doi: 10.1136/bmjopen-2025-106125.
PubMed 41387003
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)
- ClinicalTrials.gov ID
- NCT06965738
- Acronym / sponsor ID
- BOLT / 24-5894
- Keywords
- Transoral Robotic Surgery, Buccal Fat, Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trans-oral robotic surgery (TORS) for oropharyngeal cancers have transformed how oropharyngeal cancers are managed, allowing for minimally invasive surgical access to remove tumors of the tonsil and base of tongue. While large incisions and open approaches can be avoided, oropharyngeal defects following TORS are traditionally left as an open wound to heal by secondary intention, resulting in significant postoperative pain, and possibly dysphagia and dehydration.
While this has been highlighted as a key outcome measure, studies on acute pain following TORS have not had any standardization regarding the timing of pain measurement, and pain assessment. Only one study has assessed pain during 'movement-related pain', such as swallowing, which has been advocated as a key metric. Most studies used a visual analogue scale, however, majority failed to describe the timing of pain assessment relative to administration of analgesia, time of day, or diet. Overall, pain ratings and opioid utilization were highly variable between studies resulting in pain ratings ranging widely from 2.5-8 in the first few days postoperatively.
Based on the current evidence, multimodal analgesia resulted in the lowest pain ratings following TORS, with those that included gabapentin, a COX-2 inhibitor and acetaminophen having excellent pain control in the early postoperative period. Using these regimens, Castellanos et al. found that postoperative opioid consumption significantly decreased in the first three postoperative days. Clayburgh, et al. identified that addition of perioperative corticosteroids was safe and significantly improved diet consistency, and decreased length of hospital stay, though pain scores were minimally affected.
No study thus far has assessed the impact of surgical interventions on postoperative pain and swallowing. This single center, phase II, randomized control trial aims to evaluate the impact of the buccal fat rotational flap on the postoperative pain following TORS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transoral lateral oropharyngectomy alone | Active comparator | Procedure: No buccal fat reconstructionTransoral lateral oropharyngectomy without buccal fat reconstruction |
| Transoral lateral oropharyngectomy with buccal fat reconstruction | Experimental | Procedure: Buccal fat reconstructionTransoral lateral oropharyngectomy with buccal fat reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18
- Require a transoral robotic lateral oropharyngectomy as a result of the following conditions :
- Ability to understand and willing to sign a written informed consent
Key exclusion criteria (7 listed)
- History of prior head and neck squamous cell carcinoma, or prior head and neck radiotherapy
- Presence of retropharyngeal lymphadenopathy
- Presence of bilateral lymphadenopathy, or patients requiring bilateral neck dissections.
- Patients with trismus at baseline
- Patients with psychological risk factors for persistent opioid use or drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal fat reconstructionIpsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect | Procedure or surgery | Transoral lateral oropharyngectomy with buccal fat reconstruction |
| No buccal fat reconstructionNo reconstruction of lateral oropharyngectomy defect | Procedure or surgery | Transoral lateral oropharyngectomy alone |
Primary outcome
Postoperative pain during rest and swallowing
Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28
Postoperative pain during rest and swallowing on visual analogue scale at multiple time points
7 secondary outcomes
Surgical Complications
Time frame: 30 days postoperatively
Opioid usage
Time frame: 30 days postoperatively
Postoperative Hemorrhage
Time frame: 30 days postoperatively
Speech and Swallowing
Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Oral Diet
Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Feeding Tube Placement
Time frame: 30 days postoperatively
Blood Glucose
Time frame: 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 41387003Xie M, de Almeida J, Goldstein D, Martino R, Liu YF, Allen B, Xu W, Hueniken K, Yao CM. Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol. BMJ Open. 2025 Dec 12;15(12):e106125. doi: 10.1136/bmjopen-2025-106125.
- Individual participant dataSharing planned: Yes. De-identified data, randomization, primary and secondary outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Yao, MD FRCSC principal investigator
University Health Network, Toronto
John R de Almeida, MD MSc FRCSC study director
University Health Network, Toronto
Michael Xie, MD FRCSC study chair
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buccal fat reconstruction and No buccal fat reconstruction in people with Tonsil Neoplasm and Oropharynx Neoplasm, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Yao, MD FRCSC ((416) 340-3063, christophermkl.yao@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain during rest and swallowing (time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06965738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.