Proactive tongue-strengthening after partial/hemiglossectomy with reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kuj@ccf.org
• Phone: (216) 445-6594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.