Tongue Exercises for Oral Cancer

(T-PROSE Trial)

Overseen By Jamie Ku, MD, FACS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Distant metastasis, Prior radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tongue exercises with a special device can improve speech and swallowing after tongue cancer surgery. It targets individuals who have had part of their tongue removed, as they often struggle with speech and swallowing, impacting daily life. Participants will either receive standard care or incorporate proactive tongue exercises (Tongue Proactive Strengthening Exercise Program) into their routine. This study suits those planning to undergo surgery to remove up to half of their tongue due to cancer, who have not previously had head or neck cancer, and who can complete questionnaires in English, French, Spanish, or Simplified Chinese. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this tongue strengthening exercise program is safe?

Research has shown that tongue strengthening exercises are generally safe and can improve tongue strength and swallowing. One study found these exercises positively affected swallowing and mouth opening in patients with head and neck cancer. The exercises are easy to perform and have not shown any major side effects.

The biofeedback device used, called the Tongueometer, aids in performing these exercises effectively. Reports have not indicated any harm or discomfort from using this device. While researchers continue to study the exercises, current evidence suggests they are a safe option for improving speech and swallowing after tongue cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tongue Proactive Strengthening Exercise Program because it introduces a proactive approach to oral cancer recovery by using biofeedback-driven tongue exercises. Unlike the standard post-operative care that waits to address issues like dysarthria or dysphagia as they arise, this program aims to strengthen the tongue muscles from the start, potentially preventing these complications. By utilizing a tool called the Tongueometer, patients receive real-time feedback, enhancing the effectiveness of the exercises and promoting quicker recovery.

What evidence suggests that this tongue strengthening exercise program is effective for improving speech and swallowing after tongue cancer surgery?

Studies have shown that tongue exercises can improve tongue strength and swallowing in both healthy individuals and those with swallowing difficulties. For patients who have undergone surgery for tongue cancer, these exercises may also aid in speech and swallowing. In this trial, participants in the SOC + Interventional Group will engage in a biofeedback-driven prophylactic tongue strengthening exercise program using the Tongueometer. Research suggests that biofeedback devices, like the Tongueometer, can be effective. This device provides real-time feedback, helping patients perform exercises correctly and achieve better results. Initiating these exercises early may lead to improved long-term speech and swallowing outcomes after surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Jamie Ku, MD, FACS

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who have had surgery (partial or hemiglossectomy) to remove part of their tongue due to cancer. They should be interested in improving speech and swallowing post-surgery. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I have never had head or neck cancer.

I have never received radiation therapy.

I can fluently read and write in English, French, Spanish, or Simplified Chinese.

Exclusion Criteria

I have had radiation therapy to my head or neck area before.

My cancer has spread to distant parts of my body.

I have been treated for swallowing or speech difficulties not caused by head or neck cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo partial or hemiglossectomy and reconstruction, followed by initial recovery

2 weeks

Treatment

Participants receive a proactive tongue strengthening exercise program using the Tongueometer to improve speech and swallowing outcomes

10 days

Follow-up

Participants are monitored for speech and swallowing function improvements and quality of life outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Tongue Proactive Strengthening Exercise Program

Trial Overview The study tests if using a biofeedback device called the Tongueometer for proactive tongue strengthening exercises can improve speech and swallowing after tongue cancer surgery, compared to standard care without these exercises.

How Is the Trial Designed?

Group I: Arm 2 - SOC + Interventional Group Experimental Treatment 1 Intervention

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

Group II: Arm 1 - Standard of Care(SOC) Active Control 1 Intervention

Standard of Care (SOC): Standard post-operative care with additional intervention if dysarthria or dysphagia symptoms are not improving as expected

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07110142

Tongue Proactive Strengthening Exercise Program ... 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 ...

2. patlynk.com patlynk.com/trial/NCT07110142

T-PROSE | Tongue Strengthening Exercises for Speech ... This study focuses on helping patients who have undergone surgery for tongue cancer improve their speech and swallowing abilities. Tongue cancer often ...

3. smartpatients.com smartpatients.com/trials/NCT07110142

Tongue Proactive Strengthening Exercise Program ... This study is being done to determine whether adding a proactive tongue strengthening exercise program using a biofeedback device (the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4560920/

tongue strengthening exercises in head and neck cancer ... The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects.

5. uknowledge.uky.edu uknowledge.uky.edu/cgi/viewcontent.cgi?article=1016&context=commdisorders_etds

effectiveness of prophylactic lingual strengthening exercises ... Strengthening exercises were used in 17 studies with 12 utilizing the effortful swallow, 8 targeting the tongue, and 4 targeting the jaw. Four ...

6. withpower.com withpower.com/trial/phase-mouth-neoplasms-9-2025-be9c2

Tongue Exercises for Oral Cancer (T-PROSE Trial) Participants receive a proactive tongue strengthening exercise program using the Tongueometer to improve speech and swallowing outcomes. 10 days. Follow-up.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748920303151

Swallowing exercises for head and neck cancer patients Swallowing exercises had significant small effect on swallowing function 0.33 (95%CI = 0.00–0.65) and moderate effect on mouth opening 0.60 (95%CI = 0.21–0.99) ...