An interventional study of ESSI-SURG and Standard-of-Care in Dysphagia and Head and Neck Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Standard-of-Care
Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.
Behavioral: ESSI-SURG
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.
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 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%.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Post-Discharge Week 5
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