NCT07110142 Tongue Proactive Strengthening Exercise Program Following Partial/Hemi Glossectomy and Reconstruction
| NCT ID | NCT07110142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Oral Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-12-10 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jamie Ku, MD, FACS
PRINCIPAL INVESTIGATOR
Case Comprehensive Cancer Center, Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07110142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07110142 currently recruiting?
Yes, NCT07110142 is actively recruiting participants. Contact the research team at kuj@ccf.org for enrollment information.
Where is the NCT07110142 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07110142 clinical trial?
NCT07110142 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Jamie Ku, MD, FACS at Case Comprehensive Cancer Center, Cleveland Clinic. The trial plans to enroll 40 participants.
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