Recruiting soon
T-PROSE

Tongue 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

Oral Cancer

+ Head and Neck Cancer
Over 18 Years
+9 Eligibility Criteria

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: August 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual 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 
Principal SponsorCase Comprehensive Cancer Center
Study ContactJamie Ku, MD, FACS
Last updated: August 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Oral Cancer
Head and Neck Cancer
Criteria
5 inclusion criteria required to participate
≥18 years of age
No prior history of head and neck cancer
No prior history of radiation
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

Show More Criteria

4 exclusion criteria prevent from participating
Distant metastasis at enrollment
Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes
Prior head and neck radiation
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
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
No Intervention
Standard of Care (SOC): Standard post-operative care with additional intervention if dysarthria or dysphagia symptoms are not improving as expected
Group II
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

The Speech Handicap Index (SHI), a validated, self-administered questionnaire consisting of 30 items that assess the functional and psychosocial impact of speech disorders. Each item is rated on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Scores from all items are summed to produce a total score ranging from 0 to 120, with higher scores indicating a greater perceived speech handicap.
Secondary Objectives

MDADI: Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).

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 FoundationCleveland, United StatesSee the location
Recruiting soonOne Study Center