← Back to Search

Behavioral Intervention

Early Speech and Swallowing Therapy for Head and Neck Cancer (ESSI-SURG Trial)

N/A

Recruiting

Led By Jonathan Irish, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Patients who are planned for total glossectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-discharge week 5

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine whether early and systematic speech and swallowing therapy with speech-language pathologists can help improve the health and function of patients with oral cavity cancer, specifically tongue cancer, who are undergoing surgery.

Who is the study for?

This trial is for newly diagnosed patients with at least T2 stage tongue cancer, scheduled for partial tongue removal and reconstruction surgery. They should be able to eat on their own after surgery and must understand English well.

What is being tested?

The study tests if early intervention by speech-language pathologists (SLPs) before problems start can help head and neck cancer patients recover better post-surgery. It compares this new approach (ESSI-SURG) with the usual care given.

What are the potential side effects?

Since this trial involves non-drug interventions like speech and swallowing therapy, side effects are minimal but may include discomfort or fatigue from the exercises prescribed by the SLPs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am newly diagnosed with stage T2 or higher tongue cancer and will have surgery and reconstruction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for a surgery to remove my entire tongue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-discharge week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-discharge week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-discharge week 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study feasibility as measured by attrition

Study feasibility as measured by data fidelity for clinician assessments

Study feasibility as measured by data fidelity for patient-reported outcomes

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 - InterventionExperimental Treatment1 Intervention

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

Group II: Arm 1 - ControlActive Control1 Intervention

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.

0 / 2Eligibility criteria met