Recruiting
ESSI-SURG

Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ESSI-SURG

+ Standard-of-Care
Behavioral
Who is being recruted

Dysphagia

+ Head and Neck Cancer
Over 18 Years
+3 Eligibility Criteria

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: March 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2023Actual 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: March 14, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Dysphagia
Head and Neck Cancer
Criteria
2 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
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
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.
Group II
Experimental
Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.
Study Objectives
Primary Objectives

Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate \>90%.

Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of \<10%.

Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>80% for clinical assessments.

Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>90% for patient reported outcomes.

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 NetworkToronto, CanadaSee the location
Recruiting
One Study Center