Tongue Proactive Strengthening Exercise Program Following Partial/Hemi Glossectomy and Reconstruction

NCT07110142 | Recruiting DMC

• 1 other identifier: CASE6325
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Speech-Language Pathology; Hemiglossectomy; Tongueometer

Outcome Measures

Primary Outcomes (1)

• Quality of life patient report outcome (PRO) as assessed by Speech Handicap Index(SHI)

  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.

  6 months post-treatment

Secondary Outcomes (1)

• Quality of life patient report outcome (PRO) as assessed by MD Anderson Dysphagia Inventory (MDADI)

  6 months post-treatment

Study Arms (2)

Arm 1 - Standard of Care(SOC)

NO INTERVENTION

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

Arm 2 - SOC + Interventional Group

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

Other: Tongueometer

Interventions

Tongueometer OTHER

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.

Arm 2 - SOC + Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• Sufficiently fluent in written English, French, Spanish or Simplified Chinese to complete the study outcomes questionnaires

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jamie Ku, MD, FACS

  Case Comprehensive Cancer Center, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Ku, MD, FACS

CONTACT

(216) 445-6594; kuj@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)