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

Trial Summary

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 data supports the effectiveness of the treatment for speech rehabilitation in tongue cancer patients?

Research shows that using a palatal augmentation prosthesis (PAP) can improve speech clarity and swallowing in patients who have had part of their tongue removed due to cancer. Studies have found that PAP helps with speech intelligibility and overall communication, especially when combined with other therapies like speech therapy. ^{1 2 3 4 5}

Is the palatal augmentation prosthesis (PAP) safe for use in humans?

The palatal augmentation prosthesis (PAP) has been used in various studies for conditions like speech and swallowing disorders, often related to tongue cancer and other diseases. These studies suggest that PAP is generally safe for use in humans, as it is used to help improve speech and swallowing functions without reported safety concerns. ^{1 2 4 5 6}

How is the Palatal Augmentation Prosthesis (PAP) treatment different from other treatments for tongue cancer?

The Palatal Augmentation Prosthesis (PAP) is unique because it is an intraoral device specifically designed to improve speech and swallowing functions in patients who have lost tongue tissue due to cancer. Unlike other treatments, PAP directly addresses the physical changes in the mouth by providing structural support, which helps in better articulation and swallowing. ^{1 2 3 5 7}

What is the purpose of this trial?

This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality post-surgery. This is a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion of the tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing, is not routinely provided.

Research Team

Stephanie M Munz, DDS

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Changes in tongue pressure and dysphagia at oral cancer patients by palatal augmentation prosthesis. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Long term rehabilitation of a total glossectomy patient. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Structure of a New Palatal Plate and the Artificial Tongue for Articulation Disorder in a Patient with Subtotal Glossectomy. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

Palatal augmentation prosthesis (PAP) can improve swallowing function for the patients in rehabilitation hospital. [2020]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Palatal augmentation prostheses in individuals treated for head and neck cancer: Effects on speech and oral transport. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

A Case of Dysphagia and Dysarthria Improved by Flexible-palatal Lift/augmentation Combination Prosthesis. [2023]