Recruiting soon

T-PROSETongue Strengthening Exercises for Speech and Swallowing in Tongue Cancer Surgery Patients

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What is being tested

Tongueometer

Other
Who is being recruted

Head and Neck Neoplasms+3

+ Stomatognathic Diseases

+ Mouth Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorCase Comprehensive Cancer Center
Study ContactJamie Ku, MD, FACS
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on helping patients who have undergone surgery for tongue cancer improve their speech and swallowing abilities. Tongue cancer often requires removing part of the tongue, which can severely impact these functions that are crucial for daily life. While reconstructive surgery has advanced, many patients still struggle with speech and swallowing, affecting their quality of life. The goal is to evaluate how a proactive tongue exercise program can help improve these functions. This research is vital because it could lead to better care standards and potentially improve the lives of many patients who have undergone similar surgeries. Participants in this study will be involved in a tongue strengthening exercise program after their surgery. The exercises will be guided by biofeedback from a device, which helps ensure the exercises are done correctly and effectively. Researchers will measure the success of this program using both objective tests and subjective feedback, like how well participants feel they can speak and swallow. The study aims to gather critical data that could influence how speech and swallowing rehabilitation is conducted nationwide, offering a structured approach that could become a standard part of care for patients with oral cancer.

Official TitleImpact of Tongue Proactive Strengthening Exercise Program on Speech and Swallowing Outcomes Following Partial/Hemiglossectomy and Reconstruction 
NCT07110142
Principal SponsorCase Comprehensive Cancer Center
Study ContactJamie Ku, MD, FACS
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsStomatognathic DiseasesMouth DiseasesMouth NeoplasmsNeoplasmsNeoplasms by Site

Criteria

Inclusion Criteria: 1. ≥18 years of age 2. No prior history of head and neck cancer 3. No prior history of radiation 4. Planned to undergo resection of ≤50% of the native tongue (partial/hemiglossectomy) with immediate reconstruction, including free flap reconstruction, and with or without neck dissection 5. Sufficiently fluent in written English, French, Spanish or Simplified Chinese to complete the study outcomes questionnaires Exclusion Criteria: 1. Distant metastasis at enrollment 2. Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes 3. Prior head and neck radiation 4. Requires mandibulectomy or \>50% resection of native tongue

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
SOC + Interventional Group: Standard post-operative care with biofeedback-driven prophylactic tongue strengthening exercise program using the Tongueometer and the routine interventions if dysarthria or dysphagia symptoms are not improving appropriately

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, United StatesSee the location
Recruiting soonOne Study Center