An interventional study of Palatal Augmentation Prosthesis (PAP) and Articulation Therapy in Tongue Neoplasms, Tongue Cancer and Oral Cancer, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 73 studies in Tongue Neoplasms with a site in United States — 8 open to participants now, 11 under way, 2 of them phase 3. Tongue Neoplasms · United States.
Among the 73 studies in Tongue Neoplasms with a site in United States, this one is the 33rd largest by planned enrollment of the 61 interventional ones that give a count, is one of 2 that started in 2018, is one of 13 with no phase, reaches primary completion later than 6 of the 10 other live ones, and was the 63rd registered.
121 studies on the registry are indexed under Tongue Neoplasms; 12 are open to participants now.
Browse Tongue Neoplasms studies →8 of the 73 studies in Tongue Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Tobias Todsen · Sites in United States, Denmark, Italy and 2 more countries
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Tongue Neoplasms studies recruiting now, 9 (82%) set no upper age limit and 1 (9%) stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
73 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 32 · Phase 3 6 · Phase 4 1
First in 1999; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is close to the median of 42 across 93 interventional studies indexed under Tongue Neoplasms.
Median enrollment 43 across the 61 interventional studies, 130 across the 9 observational. Of the 56 that completed or were terminated, 23 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 73 have an industry lead sponsor. The 10 most frequent:
University of Michigan is the lead sponsor of 1,507 studies on the registry; 193 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 1 study filed under Tongue Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Tongue Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04870762M.D. Anderson Cancer CenterCustomized 3D Printed Oral Stents During Head and Neck Radiotherapy | 2026-12-31 |
| NCT01473784Ohio State University Comprehensive Cancer CenterTransoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck | 2026-12-31 |
| NCT06915454Vanderbilt-Ingram Cancer CenterHigh-Resolution PET-CT Imaging for Surgical Margin Visualization | 2027-05 |
| NCT07203911Tobias TodsenSurgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial | 2027-09-15 |
Add all 4 to your calendar (.ics) → With an account.
Among the 73 studies in Tongue Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
This study will randomize patients into two arms; one for oral cancer patients that receive a small device, similar to a denture, called a PAP. The other arm will be patients who serve as a control and will not receive a PAP.
The PAP requires patients to have a dental mold created. A dentist customizes the PAP to specifically fit the individual's mouth.
The study will investigate whether the PAP improves speech following tongue cancer as measured by three different scales. Both groups will see a speech language therapist for additional measures of speech evaluation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm
Device: Palatal Augmentation Prosthesis (PAP) · Other: Articulation Therapy
This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.
Other: Articulation Therapy
The palatal augmentation prosthesis, or PAP can improve speech and swallowing functions through reshaping the palatal contours. This may improve the contact between the tongue and hard palate as a person speaks or eats. It is meant to be created after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and articulation therapy are necessary for this therapy to be effective.
Subjects will receive the standard of care speech and articulation therapy in either arm.
Also known as: Speech Therapy
Word intelligibility
The Assessment of Intelligibility of Dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency. The AIDS score will be measured at baseline before surgery for tongue cancer, then after surgery at the timepoints of one month, three months, six months and one year. Six months is the primary time point measurement. Measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of separate un-related words.
Time frame: 6 months
Sentence intelligibility
The Assessment of intelligibility of dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency and will be measured at baseline before surgery for tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of words in sentences.
Time frame: 6 months
Articulation at the word level of phonemes (consonant sounds)
The Goldman Fristoe 2 test of Articulation sounds in words subtest (GFTA2) is a standardized, validated and reliable tool that systematically assesses articulation of phonemes (consonant sounds). It offers normative data from ages 2 through 21. This will be measured at baseline pre-treatment of tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured is the raw score generated from the test.
Time frame: 6 months
Patient satisfaction with speech
The Speech Handicap Index (SHI) is designed to evaluate an individual's speech function and corresponding psycho-social factors. This will be measured at baseline pre-treatment of tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured is the mean score of the survey.
Time frame: 6 months
Started Jan 2018 (actual). Primary completion is estimated for Jan 2028, 120 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.