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Prosthesis
Speech Rehabilitation for Tongue Cancer (PGSRT Trial)
N/A
Recruiting
Led By Stephanie M Munz, DDS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a new diagnosis of a T1/T2 tongue cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
PGSRT Trial Summary
This trial will test whether a palatal augmentation prosthesis can help improve speech and swallowing function in people with tongue cancer.
Who is the study for?
This trial is for individuals newly diagnosed with early-stage (T1/T2) tongue cancer. Participants must have enough upper teeth to support a dental device used in the study. Those with recurring tongue cancer or previous radiation therapy in the head and neck area are not eligible.Check my eligibility
What is being tested?
The study is testing two methods to help speech and swallowing after oral cancer treatment: a Palatal Augmentation Prosthesis (PAP), which is a special dental device, and Articulation Therapy, which is a type of speech therapy. The effectiveness of these interventions will be compared scientifically.See study design
What are the potential side effects?
While specific side effects are not detailed here, potential issues may include discomfort from wearing the prosthesis, challenges adapting to it during speaking or swallowing, and possible irritation inside the mouth.
PGSRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with early-stage tongue cancer.
PGSRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Word intelligibility
Secondary outcome measures
Articulation at the word level of phonemes (consonant sounds)
Patient satisfaction with speech
Sentence intelligibility
+1 morePGSRT Trial Design
2Treatment groups
Experimental Treatment
Group I: Prosthesis + Articulation TherapyExperimental Treatment2 Interventions
This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.
Group II: No Prosthesis; Articulation Therapy OnlyExperimental Treatment1 Intervention
This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,482 Total Patients Enrolled
Stephanie M Munz, DDSPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy for head or neck cancer before.My cancer has come back after treatment.I have been newly diagnosed with early-stage tongue cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Prosthesis + Articulation Therapy
- Group 2: No Prosthesis; Articulation Therapy Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are partaking in this clinical trial at its fullest capacity?
"Affirmative. Clinicaltrials.gov displays that this trial is actively seeking participants, with an initial post date of January 2nd 2018 and a recent update on February 4th 2022. The study requires 40 patients from one medical centre to participate."
Answered by AI
Is enrollment still open for this scientific investigation?
"Per the information accessible on clinicaltrials.gov, this research trial is seeking out patient volunteers and has been since it was posted in early 2018 with its latest update occurring in late 2022."
Answered by AI
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