Clinical trial NCT06192771: Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
Official title: Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Head and Neck Cancer
Keywords: dysphagia
head and neck cancer
speech language pathology
surgery
speech
early intervention
medical outcomes
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Study feasibility as measured by rate of accrual
timeFrame: Baseline to Post-Discharge Week 5
measure: Study feasibility as measured by attrition
timeFrame: Baseline to Post-Discharge Week 5
measure: Study feasibility as measured by data fidelity for clinician assessments
timeFrame: Baseline to Post-Discharge Week 5
measure: Study feasibility as measured by data fidelity for patient-reported outcomes
timeFrame: Baseline to Post-Discharge Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Rosemary Martino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Jonathan Irish, MD
role: PRINCIPAL_INVESTIGATOR
References: