Proactive tongue-strengthening after partial/hemiglossectomy with reconstruction

Impact of Tongue Proactive Strengthening Exercise Program on Speech and Swallowing Outcomes Following Partial/Hemiglossectomy and Reconstruction

This program tests whether adding a proactive tongue-strengthening exercise using a Tongueometer biofeedback device helps adults who undergo partial or hemi-glossectomy with reconstruction improve speech and swallowing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Case Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT07110142 on ClinicalTrials.gov

What this trial studies

This interventional study introduces a structured, proactive tongue-strengthening exercise program using a Tongueometer biofeedback device for patients undergoing partial or hemiglossectomy with immediate reconstruction. Participants receive the exercise program early after surgery in addition to usual postoperative care, and speech and swallowing outcomes are tracked over time using validated questionnaires and functional measures. The trial compares outcomes from the proactive program to standard symptom-driven therapy to see if earlier, device-guided strengthening yields better long-term function. Eligible adults must have ≤50% native tongue resection, no prior head and neck cancer or radiation, and be able to complete questionnaires in English, French, Spanish, or Simplified Chinese.

Who should consider this trial

Good fit: Adults 18 or older undergoing resection of ≤50% of the native tongue (partial or hemiglossectomy) with immediate reconstruction who have no prior head and neck cancer or radiation and can complete study questionnaires in English, French, Spanish, or Simplified Chinese.

Not a fit: Patients with distant metastases, prior head and neck radiation, prior speech-language treatment for non-head-and-neck causes, or those requiring mandibulectomy or >50% tongue resection are excluded and unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve recovery of speech and swallowing and be added to standard post-operative care.

How similar studies have performed: Previous small studies of tongue-strengthening exercises and biofeedback devices have reported improvements in tongue strength and some swallow outcomes, but evidence is limited and using a proactive post-operative program after glossectomy is relatively novel.

Eligibility 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

Where this trial is running

Cleveland, Ohio

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jamie Ku, MD, FACS — Case Comprehensive Cancer Center, Cleveland Clinic
• Study coordinator: Jamie Ku, MD, FACS

Conditions Oral Cancer; Head and Neck Cancer; Speech-Language Pathology; Hemiglossectomy; Tongueometer