Speech Rehabilitation for Tongue Cancer

(PGSRT Trial)

Overseen By Mary Burton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Recurrent disease, Prior head and neck radiation, Inadequate maxillary dentition

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve speech and swallowing for individuals who have had part of their tongue removed due to cancer. It will test a device called the Palatal Augmentation Prosthesis (PAP), which is not typically provided for smaller tongue cancers. Participants will be divided into two groups: one will receive the prosthesis along with standard speech therapy, while the other will receive only the therapy. This trial targets those newly diagnosed with smaller tongue cancers, specifically T1 or T2, who have not undergone head and neck radiation and have sufficient upper teeth to support the prosthesis. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for improving quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the palatal augmentation prosthesis (PAP) is safe for speech rehabilitation after tongue cancer surgery?

Research has shown that the palatal augmentation prosthesis (PAP) is generally safe for improving speech and swallowing. Studies indicate that PAP can reshape the roof of the mouth to aid these functions after tongue surgery. Users of PAPs have experienced clearer speech and easier swallowing.

These studies have reported no major safety issues. PAPs have been safely used in individuals with similar conditions, such as those recovering from certain types of strokes, suggesting that PAPs are well-tolerated with minimal risk of side effects.

The evidence so far supports PAP as a safe option for helping individuals regain speech and swallowing abilities after tongue cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Palatal Augmentation Prosthesis (PAP) for speech rehabilitation in tongue cancer patients because it offers a fresh approach to overcoming speech difficulties. Unlike standard articulation therapy alone, which relies on exercises to improve speech clarity, the PAP physically adjusts the shape of the oral cavity to aid in clearer speech production. This prosthetic solution aims to provide immediate structural support, potentially speeding up the recovery of speech abilities. By combining this with traditional therapy, the goal is to enhance overall treatment effectiveness and quality of life for patients.

What evidence suggests that the Palatal Augmentation Prosthesis (PAP) is effective for speech rehabilitation in tongue cancer patients?

Research has shown that a palatal augmentation prosthesis (PAP) can greatly improve speech and swallowing in patients with tongue cancer. A review found that PAP helps by altering the shape of the roof of the mouth, facilitating tongue contact for speaking and swallowing. In one study, all patients using PAP reported improved speech, and some found it easier to move food and saliva in their mouths. In this trial, one group will receive both PAP and standard articulation therapy, while another group will receive only articulation therapy. These findings suggest that using PAP alongside speech therapy can be very effective in improving speech after tongue cancer surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephanie M Munz, DDS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals newly diagnosed with early-stage (T1/T2) tongue cancer. Participants must have enough upper teeth to support a dental device used in the study. Those with recurring tongue cancer or previous radiation therapy in the head and neck area are not eligible.

Inclusion Criteria

I have been newly diagnosed with early-stage tongue cancer.

Exclusion Criteria

I have had radiation therapy for head or neck cancer before.

My cancer has come back after treatment.

Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into two arms: one receiving a palatal augmentation prosthesis (PAP) with standard articulation therapy, and the other receiving only standard articulation therapy.

6 months

Regular visits for therapy and assessments

Follow-up

Participants are monitored for speech and swallowing improvements, with assessments at one month, three months, six months, and one year post-treatment.

6 months

Assessments at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Articulation Therapy
• Palatal Augmentation Prosthesis (PAP)

Trial Overview The study is testing two methods to help speech and swallowing after oral cancer treatment: a Palatal Augmentation Prosthesis (PAP), which is a special dental device, and Articulation Therapy, which is a type of speech therapy. The effectiveness of these interventions will be compared scientifically.

How Is the Trial Designed?

Group I: Prosthesis + Articulation Therapy Experimental Treatment 2 Interventions

This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm

Group II: No Prosthesis; Articulation Therapy Only Experimental Treatment 1 Intervention

This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.

Palatal Augmentation Prosthesis (PAP) is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Palatal Augmentation Prosthesis for:

• Speech rehabilitation for patients with tongue cancer
• Swallowing rehabilitation for patients with tongue cancer

Approved in European Union as Palatal Augmentation Prosthesis for:

• Speech rehabilitation for patients with tongue cancer
• Swallowing rehabilitation for patients with tongue cancer

Approved in Japan as Palatal Augmentation Prosthesis for:

• Speech rehabilitation for patients with tongue cancer
• Swallowing rehabilitation for patients with tongue cancer

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Fitting palatal augmentation prostheses (PAPs) improved swallowing function in 18 elderly patients with low body mass index, leading to the resolution of aspiration in 2 patients and elimination of pharyngeal residue in 3 patients.

The study showed significant improvements in swallowing dynamics, including shortened pharyngeal delay and transit times, indicating that PAPs can effectively reduce post-swallowing residue due to decreased muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palatal augmentation prosthesis (PAP) can improve swallowing function for the patients in rehabilitation hospital. Yoshida, M., Endo, Y., Nishimura, R., et al.[2020]

This study aims to evaluate the effectiveness of a newly designed soft palatal augmentation prosthesis (PAP) in improving speech (dysarthria) and swallowing (dysphagia) in patients with cerebrovascular disease, using a randomized controlled trial design with primary outcomes focused on intelligibility and pharyngeal transit time.

The research will compare rehabilitation outcomes with and without the use of soft PAP, hypothesizing that early intervention with the prosthesis will lead to better improvements in articulation and swallowing functions, potentially enhancing the quality of life for affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial. Yokoyama, T., Mukai, T., Kodama, N., et al.[2022]

The use of a palatal plate (PP) and an artificial tongue (KAT) significantly improved speech intelligibility in a patient with severe articulation disorder following glossectomy and segmental mandibulectomy, as shown by standardized tests.

Patients with hard tissue defects can benefit from the combined use of PP and KAT, suggesting that these prostheses can effectively address various speech challenges related to significant tissue loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structure of a New Palatal Plate and the Artificial Tongue for Articulation Disorder in a Patient with Subtotal Glossectomy. Kozaki, KI., Kawakami, S., Konishi, T., et al.[2019]

The palatal augmentation prosthesis (PAP) significantly increases tongue pressure in patients with dysphagia, indicating its effectiveness in improving swallowing function.

Patients using PAP showed notable improvements in the Videofluoroscopic Dysphagia Scale (VDS), particularly in oral phase swallowing and contact between the tongue and palate, suggesting enhanced swallowing mechanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in tongue pressure and dysphagia at oral cancer patients by palatal augmentation prosthesis. Kuniyuki, I., Hisaoka, T., Ikeda, R., et al.[2022]

In a study of 20 patients with head and neck cancer, the use of palatal augmentation prostheses (PAP) significantly improved the articulation of velar sounds in 12 out of 19 patients, indicating enhanced speech clarity.

Additionally, 12 patients reported an overall improvement in their speech, and 7 patients experienced better transport of food or saliva, suggesting that PAPs can positively impact both communication and swallowing functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palatal augmentation prostheses in individuals treated for head and neck cancer: Effects on speech and oral transport. Löfhede, H., Wertsén, M., Havstam, C.[2021]

A Palatal Augmentation Prosthesis (PAP) and a mandibular tongue prosthesis can significantly improve speech intelligibility and articulation in patients who have undergone partial or total glossectomy due to oral cancer.

In a case study of a total glossectomy patient, speech therapy combined with a tongue prosthesis led to noticeable improvements in speech quality, including better intonation and loudness, even twelve years post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term rehabilitation of a total glossectomy patient. Bachher, GK., Dholam, KP.[2022]

The flexible-palatal lift/augmentation combination prosthesis (fPL/ACP) significantly improved swallowing and speech intelligibility in an 83-year-old woman with dysphagia due to motor deficits, as shown by videofluoroscopic swallowing studies and oral motor function tests.

The fPL/ACP demonstrated similar benefits to traditional palatal lift and augmentation prostheses, suggesting it is effective for patients with combined tongue and soft palate motor deficits, especially when used alongside rehabilitation and nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Dysphagia and Dysarthria Improved by Flexible-palatal Lift/augmentation Combination Prosthesis. Hirasaki, M., Takagi, D., Umeda, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11846734/

Is palatal augmentation prosthesis effective in restoring ... The results of this systematic review indicate that PAP has a significant effect in improving speech intelligibility, swallowing efficacy, masticatory function ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02584270

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers ... The palatal augmentation prosthesis, or PAP can improve speech and swallowing functions through reshaping the palatal contours. This may improve the contact ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9327658/

Changes in tongue pressure and dysphagia at oral cancer ... The palatal augmentation prosthesis (PAP) is an intraoral prosthesis used in the treatment of dysphagia. The objective of the study is to examine the effect ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hed.26124

Palatal augmentation prostheses in individuals treated for ... All six patients treated for tongue cancer reported speech improvement. Seven of 20 patients reported better transport of food or saliva.

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/7/e060040

Efficacy of soft palatal augmentation prosthesis for oral ... The aim of this study is to investigate whether soft PAP can improve dysarthria and dysphagia occurring as cerebrovascular disease sequelae.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9289020/

Efficacy of soft palatal augmentation prosthesis for oral ... The aim of this study is to investigate whether soft PAP can improve dysarthria and dysphagia occurring as cerebrovascular disease sequelae.

7. researchgate.net researchgate.net/figure/Type-of-glossectomy-and-palatal-augmentation-prosthesis-PAP-or-tongue-prosthesis-TP_tbl4_310428600

Type of glossectomy and palatal augmentation prosthesis ... This prospective pilot study compares the safety and functional outcomes associated with using a chimeric innervated muscle and fasciocutaneous flap for soft ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1883195818304419

Palatal augmentation prosthesis (PAP) can improve ... The results of this study showed that PAPs could be beneficial as treatment devices for reducing post-swallowing pyriform sinus residue formation due to ...