DysphagiaESSI-SURGNCT06192771
Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
A study testing ESSI-SURG and Standard-of-Care in people with Dysphagia and Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Head and Neck Cancer
- What is being tested?
- ESSI-SURG and Standard-of-Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- 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
- Newly diagnosed patients with at least T2 stage tongue SCC who are planned for partial glossectomy and free flap reconstruction and are anticipated to achieve a post-operative independent oral intake.
- Proficient in spoken and written English
Who cannot join
- Patients who are planned for total glossectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G2C4
Trixie Reichardt, MHSc, 4169463826, trixie.reichardt@uhnresearch.ca
About this study
Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency.
This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.
- Conditions
- Dysphagia, Head and Neck Cancer
- Being tested
- ESSI-SURG, Standard-of-Care
- Keywords
- dysphagia, head and neck cancer, speech language pathology, surgery, speech, early intervention, medical outcomes
- Medical subject headings
- Deglutition Disorders, Head and Neck Neoplasms, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESSI-SURGBehavioural
Patients will receive 3 face-to-face sessions with a speech-language pathologist (SLP), each with a specific goal, namely: pre-surgical educational, a post-operative day 3 therapy, and post-operative day 7 therapy. Following discharge from hospital, participants will be seen by an SLP for 4 weekly sessions, offered via telehealth or face-to-face depending on the patient's clinic schedule and/or availability.
Standard-of-CareBehavioural
Participants will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Control | Active comparator | Participants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report. Receives: Behavioral: Standard-of-Care |
| Arm 2 - Intervention | Experimental | Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP. Receives: Behavioral: ESSI-SURG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility as measured by rate of accrual
Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate >90%.
Measured: Baseline to Post-Discharge Week 5
Study feasibility as measured by attrition
Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of <10%.
Measured: Baseline to Post-Discharge Week 5
Study feasibility as measured by data fidelity for clinician assessments
Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >80% for clinical assessments.
Measured: Baseline to Post-Discharge Week 5
Study feasibility as measured by data fidelity for patient-reported outcomes
Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >90% for patient reported outcomes.
Measured: Baseline to Post-Discharge Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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 N/A
- Primary purpose
- Prevention
- 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, Rosemary Martino, PhD, University Health Network, Toronto
- Investigators
- Rosemary Martino, PhD, Principal investigator, University Health Network, TorontoJonathan Irish, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192771
- Sponsor's protocol ID
- 23-5503
- Acronym
- ESSI-SURG
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
- ClinicalTrials.gov ID
- NCT06192771
- Acronym / sponsor ID
- ESSI-SURG / 23-5503
- Conditions
- Dysphagia, Head and Neck Cancer
- Keywords
- dysphagia, head and neck cancer, speech language pathology, surgery, speech, early intervention, medical outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency.
This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Control | Active comparator | Behavioral: Standard-of-CareParticipants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report. |
| Arm 2 - Intervention | Experimental | Behavioral: ESSI-SURGParticipants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed patients with at least T2 stage tongue SCC who are planned for partial glossectomy and free flap reconstruction and are anticipated to achieve a post-operative independent oral intake.
- Proficient in spoken and written English
Key exclusion criteria (1 listed)
- Patients who are planned for total glossectomy
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 |
|---|---|---|
| ESSI-SURGPatients will receive 3 face-to-face sessions with a speech-language pathologist (SLP), each with a specific goal, namely: pre-surgical educational, a post-operative day 3 therapy, and post-operative day 7 therapy. Following discharge from hospital, participants will be seen by an SLP for 4 weekly sessions, offered via telehealth or face-to-face depending on the patient's clinic schedule and/or availability. | Behavioural | Arm 2 - Intervention |
| Standard-of-CareParticipants will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report. | Behavioural | Arm 1 - Control |
Primary outcome
Study feasibility as measured by rate of accrual
Time frame: Baseline to Post-Discharge Week 5
Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate >90%.
Study feasibility as measured by attrition
Time frame: Baseline to Post-Discharge Week 5
Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of <10%.
Study feasibility as measured by data fidelity for clinician assessments
Time frame: Baseline to Post-Discharge Week 5
Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >80% for clinical assessments.
Study feasibility as measured by data fidelity for patient-reported outcomes
Time frame: Baseline to Post-Discharge Week 5
Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >90% for patient reported outcomes.
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 3 Jun 2026.
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
Rosemary Martino, PhD principal investigator
University Health Network, Toronto
Jonathan Irish, MD principal investigator
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 study testing ESSI-SURG and Standard-of-Care in people with Dysphagia and Head and Neck Cancer, 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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.
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 Trixie Reichardt, MHSc (416-946-3826, trixie.reichardt@uhnresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility as measured by rate of accrual (time frame: Baseline to Post-Discharge Week 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.