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Expiratory Muscle Strength Training for Head and Neck Cancers
N/A
Recruiting
Led By Barbara Pauloski, Ph.D.
Research Sponsored by University of Wisconsin, Milwaukee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial looks at whether training the muscles used for swallowing can help people who've had radiation therapy for head and neck cancer, 5+ years ago.
Who is the study for?
This trial is for long-term survivors of head and neck cancer who were treated with radiation or chemoradiotherapy at least 5 years ago. Participants must have swallowing difficulties related to their cancer treatment, be able to follow directions, and engage in rehabilitation exercises.Check my eligibility
What is being tested?
The study tests whether expiratory muscle strength training (EMST) improves swallowing function, oral intake, and quality of life related to swallowing in individuals who've had head and neck cancer treatments.See study design
What are the potential side effects?
Potential side effects are not detailed but may include discomfort from the exercises or exacerbation of existing conditions like untreated hypertension or gastroesophageal reflux if participants haven't been cleared by a physician.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Extent of hyoid movement (mm)
Level of Oral Intake (number)
Maximum Expiratory Pressure (MEP) cm H20
+4 moreOther outcome measures
Eating Assessment Tool (EAT-10) (number)
M.D. Anderson Dysphagia Inventory (MDADI) (number)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention
Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions
Group II: Pharyngeal Muscle Strengthening ExercisesActive Control1 Intervention
Patients randomized to Standard Care will receive swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Expiratory Muscle Strength Training
2016
N/A
~50
Find a Location
Who is running the clinical trial?
Froedtert HospitalOTHER
9 Previous Clinical Trials
10,696 Total Patients Enrolled
University of Wisconsin, MilwaukeeLead Sponsor
49 Previous Clinical Trials
6,613 Total Patients Enrolled
Medical College of WisconsinOTHER
610 Previous Clinical Trials
1,162,693 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have trouble swallowing that is not caused by your head and neck cancer treatment, such as memory problems or a past stroke.You are currently having trouble with swallowing. This can include feeling like food is getting stuck in your throat, having a hard time moving food from your mouth to your throat, or coughing/choking when you eat or drink.
Research Study Groups:
This trial has the following groups:- Group 1: Expiratory Muscle Strength Training
- Group 2: Pharyngeal Muscle Strengthening Exercises
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 people have consented to participate in this research trial?
"Affirmative. Data hosted on clinicaltrials.gov states that this medical trial is actively seeking patients, with the first posting being made on September 10th 2018 and the most recent update occurring May 16th 2022. A total of 20 participants need to be recruited from 1 facility."
Answered by AI
Is this experiment open for enrollment?
"Affirmative. Per the information available on clinicaltrials.gov, this medical trial issued its call for patients as of September 10th 2018 and has since been updated on May 16th 2022. A total of 20 volunteers are being recruited from a single site."
Answered by AI
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