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Prosthesis guided speech rehabilitation of T1/T2 cancers of the tongue (PGSRT): a randomized clinical trial

Primary Investigator
Munz, Stephanie
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT02584270
UM Number
2018.100
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Head, Neck, and Endocrine Malignancies
ID (Protocol)
11839
Secondary Protocol No
HUM00093723
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Lip, Oral Cavity and Pharynx
Summary
This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis as a therapeutic modality in a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common morbidity of oral cancer therapy, namely speech and swallowing function in a population of patients with T1/T2 tumors of the tongue who are not currently routinely recommended for a palatal augmentation prosthesis.

Eligibility: 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