Clinical trial · Interventional
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
| Tongue Neoplasms | Tongue Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Articulation Therapy | Other | — | UNRESOLVED |
| Palatal Augmentation Prosthesis (PAP) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prosthesis + Articulation Therapy
- description
- This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm
- interventionNames
- Device: Palatal Augmentation Prosthesis (PAP)
- Other: Articulation Therapy
- type
- OTHER
- label
- No Prosthesis; Articulation Therapy Only
- description
- This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.
- interventionNames
- Other: Articulation Therapy
Primary outcomes (1)
- measure
- Word intelligibility
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a new diagnosis of a T1/T2 tongue cancer Exclusion Criteria: * Patients with recurrent disease * Patients with a history of prior head and neck radiation therapy * Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis
References
Publications (0)
Data not yet available