Recruiting

ESSI-SURGFeasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

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What is being tested

ESSI-SURG

+ Standard-of-Care

Behavioral
Who is being recruted

Deglutition Disorders+6

+ Digestive System Diseases

+ Esophageal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorUniversity Health Network, Toronto
Study ContactTrixie Reichardt, MHSc
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2023

Actual date on which the first participant was enrolled.

Oral cavity cancer is a widespread health issue, with tongue cancer being a particularly common form. People diagnosed with oral cancers often struggle with painful and difficult swallowing, known as dysphagia, which can lead to significant weight loss and other health complications like pneumonia and malnutrition. These swallowing difficulties also greatly affect the quality of life for survivors. Studies suggest that working with speech-language pathologists (SLPs) before issues arise, especially for those undergoing surgery, can be beneficial. Learning strategies to manage swallowing may help reduce complications and the need for feeding tubes, thus improving overall recovery. This study explores the feasibility of starting a clinical trial to evaluate the impact of early speech and swallowing interventions provided by SLPs for patients undergoing surgery for head and neck cancer. Participants will receive guidance from an SLP on how to manage swallowing issues before their surgery. The study will track patients' health and functional outcomes by comparing their condition before treatment and one month afterward. The goal is to understand if early intervention can lead to better health outcomes and improve the overall recovery experience for these patients.

Official TitleFeasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically 
Principal SponsorUniversity Health Network, Toronto
Study ContactTrixie Reichardt, MHSc
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteOtorhinolaryngologic DiseasesPharyngeal Diseases

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University Health Network

Toronto, CanadaSee the location
Recruiting
One Study Center