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

Head and Neck Cancer Clinical Trial

— ESSI-SURG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192771
• Other study ID #: 23-5503
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: Trixie Reichardt, MHSc
• Phone: 416-946-3826
• Email: trixie.reichardt[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study feasibility as measured by rate of accrual	Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate >90%.	Baseline to Post-Discharge Week 5
Primary	Study feasibility as measured by attrition	Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of <10%.	Baseline to Post-Discharge Week 5
Primary	Study feasibility as measured by data fidelity for clinician assessments	Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >80% for clinical assessments.	Baseline to Post-Discharge Week 5
Primary	Study feasibility as measured by data fidelity for patient-reported outcomes	Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >90% for patient reported outcomes.	Baseline to Post-Discharge Week 5