T-PROSETongue Strengthening Exercises for Speech and Swallowing in Tongue Cancer Surgery Patients
Tongueometer
Head and Neck Neoplasms+3
+ Stomatognathic Diseases
+ Mouth Diseases
Supportive Care Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, United StatesSee the location