Tongue Proactive Strengthening Exercise Program Following Partial/Hemi Glossectomy and Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tongueometer
Other interventionThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Standard of Care(SOC)No intervention 0 interventions
Group B: Arm 2 - SOC + Interventional GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 months post-treatmentSecondary outcomes
1
Quality of life patient report outcome (PRO) as assessed by MD Anderson Dysphagia Inventory (MDADI)
MDADI: Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).
Time frame
6 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov