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Trial record 99 of 11639 for:    Oral Cancer

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT)

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ClinicalTrials.gov Identifier: NCT02584270
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie M. Munz, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Tongue Neoplasms Tongue Cancer Oral Cancer Device: Palatal Augmentation Prosthesis (PAP) Other: Articulation Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Prosthesis + Articulation Therapy
This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.
Device: Palatal Augmentation Prosthesis (PAP)
The palatal augmentation prosthesis improves speech and swallowing function through reshaping the palatal contours in order to obtain contact of the tongue to the hard palate during function. It is intended to be fabricated after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and associated articulation therapy are necessary for this therapy to be effective.

Other: Articulation Therapy
Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.
Other Name: Speech Therapy

No Prosthesis; Articulation Therapy Only
This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.
Other: Articulation Therapy
Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.
Other Name: Speech Therapy




Primary Outcome Measures :
  1. Word intelligibility [ Time Frame: 6 months ]
    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 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 will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of separate un-related words.


Secondary Outcome Measures :
  1. Sentence intelligibility [ Time Frame: 6 months ]
    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 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 will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of words in sentences.

  2. Articulation at the word level of phonemes (consonant sounds) [ Time Frame: 6 months ]
    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.

  3. Patient satisfaction with speech [ Time Frame: 6 months ]
    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.

  4. Tongue to palate contact [ Time Frame: 6 months ]
    The Complete Speech Electropalatometer with Electropalatogram (EPG) offers objective data in which to measure baseline contact of the tongue to the palate as well as changes over time. 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 percentage of data points recorded during speech function.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584270


Contacts
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Contact: Stephanie M Munz, DDS 734 936-8289 smmunz@med.umich.edu
Contact: Jennifer A Lay-Luskin, MPhil, CCRC jalay@med.umich.edu

Locations
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United States, Michigan
University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Stephanie Munz, DDS    734-936-8289    smmunz@med.umich.edu   
Contact: Jennifer A Lay-Luskin, MPhil, CCRC       jalay@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Stephanie M Munz, DDS University of Michigan

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Responsible Party: Stephanie M. Munz, Clinical Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02584270     History of Changes
Other Study ID Numbers: HUM00093723.1
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephanie M. Munz, University of Michigan:
palatal drop prosthesis

Additional relevant MeSH terms:
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Mouth Neoplasms
Tongue Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases