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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
United States
Ohio
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
Jamie Ku, MD, FACS
kuj@ccf.org
(216) 445-6594
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2029-06
Participants
Target number of participants: 40
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov