NCT06192771 Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
| NCT ID | NCT06192771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Rosemary Martino, PhD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT06192771 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06192771 currently recruiting?
Yes, NCT06192771 is actively recruiting participants. Contact the research team at trixie.reichardt@uhnresearch.ca for enrollment information.
Where is the NCT06192771 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06192771 clinical trial?
NCT06192771 is sponsored by University Health Network, Toronto. The principal investigator is Rosemary Martino, PhD at University Health Network, Toronto. The trial plans to enroll 40 participants.