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NCT Number: NCT06192771

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

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.

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Key information

Conditions

Dysphagia Behavior Communication Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases Speech Verbal Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location status: Recruiting

Location contact

Trixie Reichardt, MHSc

CONTACT

[email protected]

4169463826

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESSI-SURG

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Study feasibility as measured by rate of accrual

    Time frame: Baseline to Post-Discharge Week 5

    Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate >90%.

  2. Study feasibility as measured by attrition

    Time frame: Baseline to Post-Discharge Week 5

    Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of <10%.

  3. Study feasibility as measured by data fidelity for clinician assessments

    Time frame: Baseline to Post-Discharge Week 5

    Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >80% for clinical assessments.

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

    Time frame: Baseline to Post-Discharge Week 5

    Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of >90% for patient reported outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Trixie Reichardt, MHSc

CONTACT

[email protected]

416-946-3826

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: ESSI-SURG

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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