Recruiting

SLP Intervention

Sponsor:

University Health Network, Toronto

Code:

NCT06192771

Conditions

Dysphagia

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ESSI-SURG

Standard-of-Care

Study Details

Brief 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. 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

Study ID

NCT06192771

Start date

Dec 1, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who are planned for total glossectomy

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Arm 1 - Control

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.

experimental: Arm 2 - Intervention

Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.

Interventions

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.

Standard-of-Care

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.

Primary outcome measure

  • Study feasibility as measured by rate of accrual [ Time Frame: Baseline to Post-Discharge Week 5 ]
  • Study feasibility as measured by attrition [ Time Frame: Baseline to Post-Discharge Week 5 ]
  • Study feasibility as measured by data fidelity for clinician assessments [ Time Frame: Baseline to Post-Discharge Week 5 ]
  • Study feasibility as measured by data fidelity for patient-reported outcomes [ Time Frame: Baseline to Post-Discharge Week 5 ]

Central Contacts and Locations

Central contacts

Trixie Reichardt, MHSc

416-946-3826trixie.reichardt@uhnresearch.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Trixie Reichardt, MHSc

4169463826trixie.reichardt@uhnresearch.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 3, 2026

Last verified

Apr, 2026

Keywords

  • dysphagia
  • head and neck cancer
  • speech language pathology
  • surgery
  • speech
  • early intervention
  • medical outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-03.