Recruiting

Tongue Strengthening

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07110142

Conditions

Oral Cancer

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tongueometer

Study Details

Brief summary:

This study is being done to determine whether adding a proactive tongue strengthening exercise program using a biofeedback device (the Tongueometer) improves speech and swallowing outcomes after surgery for tongue cancer. Patients who undergo partial or hemiglossectomy often experience difficulties with speech and swallowing, which can significantly impact their quality of life. While speech and swallow therapy is typically provided in response to problems, this study investigates whether introducing structured tongue strengthening exercises with biofeedback early-can lead to better long-term outcomes. This research will help establish whether this approach should become part of standard post-operative care.

Conditions

Oral Cancer

Head and Neck Cancer

Study ID

NCT07110142

Start date

Dec 10, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Arm 1 - Standard of Care(SOC)

Standard of Care (SOC): Standard post-operative care with additional intervention if dysarthria or dysphagia symptoms are not improving as expected

experimental: Arm 2 - SOC + Interventional Group

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

Interventions

Tongueometer

The Tongueometer device features an air-filled bulb that is placed against the roof of the mouth by the tongue for resistance training. This setup allows for an initial measurement of the patient's maximum tongue strength and endurance, which helps establish goals that are specific to each patient. The device connects to a mobile application that provides visual biofeedback, ensuring consistent monitoring as the patient completes exercises using the tongue bulb for resistance. Once the patient's goals are set based on their initial measurements, the app offers two exercise modules designed to improve both tongue strength and endurance.

Primary outcome measure

  • Quality of life patient report outcome (PRO) as assessed by Speech Handicap Index(SHI) [ Time Frame: 6 months post-treatment ]

Central Contacts and Locations

Central contacts

Jamie Ku, MD, FACS

(216) 445-6594kuj@ccf.org

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Jamie Ku, MD, FACS

216-445-6594kuj@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Speech-Language Pathology
  • Hemiglossectomy
  • Tongueometer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.