This trial studies how well palatal augmentation prosthesis (PAP) works in improving speech in patients with TI or TII tongue cancers following standard of care surgery. PAP is designed to help patients speak more clearly following tongue surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02584270.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Rogel Cancer CenterStatus: Active
Contact: Stephanie Munz
Phone: 734-936-8289
PRIMARY OBJECTIVE:
I. Validate palatal augmentation speech prosthesis training on speech intelligibility and efficiency at the word level at approximately 6 months following resection and reconstruction for tongue cancer.
SECONDARY OBJECTIVES:
I. Validate palatal augmentation speech prosthesis training on speech intelligibility and efficiency at the sentence
level at approximately 6 months following resection and reconstruction for tongue cancer.
II. Determine if there is improvement in patient speech satisfaction with a palatal augmentation speech prosthesis.
III. Define the effect of radiation therapy on speech intelligibility, efficacy and function following resection and reconstruction for tongue cancer.
EXPLORATORY OBJECTIVE:
I. Identify palatal contact patterns and their impact in patients with tongue cancer resection and reconstruction.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Following standard of care surgery, patients receive PAP and undergo standard of care articulation therapy.
GROUP II: Following standard of care surgery, patients undergo standard of care articulation therapy.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorStephanie Munz
