Oral CancerT-PROSENCT07110142
Tongue Proactive Strengthening Exercise Program Following Partial/Hemi Glossectomy and Reconstruction
A study testing Tongueometer in people with Oral Cancer and Head and Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Head and Neck Cancer
- What is being tested?
- Tongueometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Jamie Ku, MD, FACS, 216-445-6594, kuj@ccf.org
About this study
Official title: Impact of Tongue Proactive Strengthening Exercise Program on Speech and Swallowing Outcomes Following Partial/Hemiglossectomy and Reconstruction
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.
Read the detailed description
The oral cavity is the most common subsite of head and neck cancers, with over 50,000 new cases diagnosed in 2023 in the United States alone. Of the various anatomic subsites of the oral cavity, the proportion of cancers arising from the tongue is the highest. Surgical resection is the mainstay of treatment and patient may additionally receive chemotherapy and radiation therapy as part of their care. However, removal of a significant portion of the muscular tongue responsible for the complex movements required for speech and swallowing function to obtain negative oncological margins may severely impact function. In recent years, microvascular free flap reconstruction at the time of ablation has become the gold standard to address the oncologic defect and help restore bulk and function to the tongue. In contrast to primary closure or healing by secondary intention, patients who have undergone a resection of a significant portion of their tongue had improved swallowing outcomes in the long term. Despite important restoration of function, however, quality of life and function related to swallowing and speech following reconstruction remain an important problem for some patients. To highlight how important swallowing function is to quality of life, a recent study of hospitalized patients identified tube feed dependence as the sixth debility as equal or worse than death. In addition, severe postoperative dysphagia has been shown to be an independent predictor of overall survival in head and neck cancer patients. This is in addition to post-surgical patients experiencing increased rates of malnutrition, higher number of aspiration events, and decreased speech intelligibility.
Nevertheless, some studies have shown that great functional outcomes can be achieved in the long-term post surgery. Recently, there has been increased effort to identify interventions that are able to improve function in the short and long terms in post-surgical patients. Surgical patients in particular present a challenging patient population, as intervention that is inappropriately early may theoretically increase the risk of peri-operative complications such as wound dehiscence, while delaying therapy may hinder the patient's ability to recover optimal post-operative function. A recent meta-analysis by Lam et al. described a total of eight studies suggesting that as a whole, early interventions increase speech, swallowing function and quality of life in the short term. However, by their own accord the type, duration and start point of the interventions vary greatly among the various studies, and there was significant heterogeneity among the oral subsites of the primary tumor that were included in each study.
Among the studies described, four limit their analyses to tongue resections. The largest of the four studies identified 134 tongue cancer patient undergoing not only resection, but also reconstruction, and early intervention starting on post-operative day 10 was associated with improved EAT-10 and FACT-HN scores in patients undergoing 10 days of tongue and lip exercises, suggesting improved perceived swallowing ability and quality of life in those having undergone this therapy . In terms of more objective measures of outcomes, a similar study of 100 tongue cancer patients by Hsiang et al demonstrated that early swallow therapy decreased the rates of aspiration events and pneumonia at one and four months post-surgery.
From a speech perspective, a systemic review of speech outcomes in patients who underwent hemiglossectomy with free flap reconstruction identified four studies including a total of 238 patients who were reconstructed using a variety of flaps, including radial forearm (RFFF), latissimus dorsi (LD), rectus abdominis (RAM) or anterolateral thigh (ALT). In the largest of those 4 studies, speech was reported as good in 29.4% of patients (clearly understandable) and acceptable in 52.9% of listeners (understandable only when context is known, requiring frequent repetition), which leaves many patients (17.7%) with unintelligible speech. The speech-specific impact on quality of life was not captured in the studies and there remains a paucity of studies investigating the use of early intervention to improve speech in patients following oncologic tongue surgery.
Despite promising data on the efficacy of speech and swallowing interventions following oncologic and reconstructive surgery of the tongue, long term prospective data remains lacking. More information is needed regarding best practices for type and timing of these interventions. Patients at our institutions are commonly referred to the SLP before and immediately after treatment in order to improve speech and prevent dysphagia. However, this is not necessarily the norm, and patients may often be referred only in response to reported speech and/or swallowing difficulties following treatment in the absence of a unified best-practice protocol for the management of post-surgical speech/swallow function. To address this gap, our study aims to compare the effectiveness of active post-surgical tongue strengthening exercise in improving speech and swallow function in patient with tongue cancer. Effectiveness will be measured using a variety of objective and subjective tools commonly used to report speech and swallow outcomes in the head and neck cancer population.
Head and neck cancer patients at our institution are commonly referred to the Speech Language Pathologist (SLP) before, during, and after cancer treatment to improve speech and swallowing. However, this is not standard at many institutions, and patients may often be referred only in response to symptoms of dysfunction following treatment. This is due to the absence of a high quality, evidence-based best-practice protocol for the management of post-treatment speech and swallow function. To address this gap, our study aims to compare the effectiveness of a proactive post-surgical tongue strengthening exercise program using device biofeedback in improving speech and swallow function in patients with tongue cancer. Effectiveness will be measured using a variety of objective and subjective tools commonly used to report speech and swallowing outcomes in the head and neck cancer population. This work will be critical in demonstrating the value of an evidence-based, device-based home tongue rehabilitation program in improving speech and swallow function for oral cancer patients undergoing cancer surgery and reconstruction. This trial will also provide key data to aid in design of a national multi-institutional clinical trial for this concept, which will have the potential to change the standard of care in how we rehabilitate oral cancer patients locoregionally and nationally.
- Conditions
- Oral Cancer, Head and Neck Cancer
- Being tested
- Tongueometer
- Keywords
- Speech-Language Pathology, Hemiglossectomy, Tongueometer
- Medical subject headings
- Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TongueometerOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard of Care(SOC) | No intervention | Standard of Care (SOC): Standard post-operative care with additional intervention if dysarthria or dysphagia symptoms are not improving as expected |
| Arm 2 - SOC + Interventional Group | Experimental | 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 Receives: Other: Tongueometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-treatment
Secondary 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).
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start10 Dec 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Ku, MD, FACS, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110142
- Sponsor's protocol ID
- CASE6325
- Acronym
- T-PROSE
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tongue Proactive Strengthening Exercise Program on Speech and Swallowing Outcomes Following Partial/Hemiglossectomy and Reconstruction
- ClinicalTrials.gov ID
- NCT07110142
- Acronym / sponsor ID
- T-PROSE / CASE6325
- Conditions
- Oral Cancer, Head and Neck Cancer
- Keywords
- Speech-Language Pathology, Hemiglossectomy, Tongueometer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The oral cavity is the most common subsite of head and neck cancers, with over 50,000 new cases diagnosed in 2023 in the United States alone. Of the various anatomic subsites of the oral cavity, the proportion of cancers arising from the tongue is the highest. Surgical resection is the mainstay of treatment and patient may additionally receive chemotherapy and radiation therapy as part of their care. However, removal of a significant portion of the muscular tongue responsible for the complex movements required for speech and swallowing function to obtain negative oncological margins may severely impact function. In recent years, microvascular free flap reconstruction at the time of ablation has become the gold standard to address the oncologic defect and help restore bulk and function to the tongue. In contrast to primary closure or healing by secondary intention, patients who have undergone a resection of a significant portion of their tongue had improved swallowing outcomes in the long term. Despite important restoration of function, however, quality of life and function related to swallowing and speech following reconstruction remain an important problem for some patients. To highlight how important swallowing function is to quality of life, a recent study of hospitalized patients identified tube feed dependence as the sixth debility as equal or worse than death. In addition, severe postoperative dysphagia has been shown to be an independent predictor of overall survival in head and neck cancer patients. This is in addition to post-surgical patients experiencing increased rates of malnutrition, higher number of aspiration events, and decreased speech intelligibility.
Nevertheless, some studies have shown that great functional outcomes can be achieved in the long-term post surgery. Recently, there has been increased effort to identify interventions that are able to improve function in the short and long terms in post-surgical patients. Surgical patients in particular present a challenging patient population, as intervention that is inappropriately early may theoretically increase the risk of peri-operative complications such as wound dehiscence, while delaying therapy may hinder the patient's ability to recover optimal post-operative function. A recent meta-analysis by Lam et al. described a total of eight studies suggesting that as a whole, early interventions increase speech, swallowing function and quality of life in the short term. However, by their own accord the type, duration and start point of the interventions vary greatly among the various studies, and there was significant heterogeneity among the oral subsites of the primary tumor that were included in each study.
Among the studies described, four limit their analyses to tongue resections. The largest of the four studies identified 134 tongue cancer patient undergoing not only resection, but also reconstruction, and early intervention starting on post-operative day 10 was associated with improved EAT-10 and FACT-HN scores in patients undergoing 10 days of tongue and lip exercises, suggesting improved perceived swallowing ability and quality of life in those having undergone this therapy . In terms of more objective measures of outcomes, a similar study of 100 tongue cancer patients by Hsiang et al demonstrated that early swallow therapy decreased the rates of aspiration events and pneumonia at one and four months post-surgery.
From a speech perspective, a systemic review of speech outcomes in patients who underwent hemiglossectomy with free flap reconstruction identified four studies including a total of 238 patients who were reconstructed using a variety of flaps, including radial forearm (RFFF), latissimus dorsi (LD), rectus abdominis (RAM) or anterolateral thigh (ALT). In the largest of those 4 studies, speech was reported as good in 29.4% of patients (clearly understandable) and acceptable in 52.9% of listeners (understandable only when context is known, requiring frequent repetition), which leaves many patients (17.7%) with unintelligible speech. The speech-specific impact on quality of life was not captured in the studies and there remains a paucity of studies investigating the use of early intervention to improve speech in patients following oncologic tongue surgery.
Despite promising data on the efficacy of speech and swallowing interventions following oncologic and reconstructive surgery of the tongue, long term prospective data remains lacking. More information is needed regarding best practices for type and timing of these interventions. Patients at our institutions are commonly referred to the SLP before and immediately after treatment in order to improve speech and prevent dysphagia. However, this is not necessarily the norm, and patients may often be referred only in response to reported speech and/or swallowing difficulties following treatment in the absence of a unified best-practice protocol for the management of post-surgical speech/swallow function. To address this gap, our study aims to compare the effectiveness of active post-surgical tongue strengthening exercise in improving speech and swallow function in patient with tongue cancer. Effectiveness will be measured using a variety of objective and subjective tools commonly used to report speech and swallow outcomes in the head and neck cancer population.
Head and neck cancer patients at our institution are commonly referred to the Speech Language Pathologist (SLP) before, during, and after cancer treatment to improve speech and swallowing. However, this is not standard at many institutions, and patients may often be referred only in response to symptoms of dysfunction following treatment. This is due to the absence of a high quality, evidence-based best-practice protocol for the management of post-treatment speech and swallow function. To address this gap, our study aims to compare the effectiveness of a proactive post-surgical tongue strengthening exercise program using device biofeedback in improving speech and swallow function in patients with tongue cancer. Effectiveness will be measured using a variety of objective and subjective tools commonly used to report speech and swallowing outcomes in the head and neck cancer population. This work will be critical in demonstrating the value of an evidence-based, device-based home tongue rehabilitation program in improving speech and swallow function for oral cancer patients undergoing cancer surgery and reconstruction. This trial will also provide key data to aid in design of a national multi-institutional clinical trial for this concept, which will have the potential to change the standard of care in how we rehabilitate oral cancer patients locoregionally and nationally.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard of Care(SOC) | No intervention | –Standard of Care (SOC): Standard post-operative care with additional intervention if dysarthria or dysphagia symptoms are not improving as expected |
| Arm 2 - SOC + Interventional Group | Experimental | Other: TongueometerSOC + 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TongueometerThe 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. | Other | Arm 2 - SOC + Interventional Group |
Primary outcome
Quality of life patient report outcome (PRO) as assessed by Speech Handicap Index(SHI)
Time frame: 6 months post-treatment
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.
1 secondary outcome
Quality of life patient report outcome (PRO) as assessed by MD Anderson Dysphagia Inventory (MDADI)
Time frame: 6 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie Ku, MD, FACS principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongueometer in people with Oral Cancer and Head and Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Ku, MD, FACS ((216) 445-6594, kuj@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life patient report outcome (PRO) as assessed by Speech Handicap Index(SHI) (time frame: 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.