Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically (ESSI-SURG)

University Health Network, Toronto

Status: Enrolling

Conditions: Dysphagia; Head and Neck Cancer

Treatments: Behavioral: ESSI-SURG; Behavioral: Standard-of-Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06192771

23-5503

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm 1 - Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard-of-Care

Arm 2 - Intervention

Experimental group

Description:

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

Treatment:

Behavioral: ESSI-SURG