Your session is about to expire
← Back to Search
EMST for Swallowing Disorders in Head and Neck Cancer Patients
N/A
Recruiting
Led By Barbara Pauloski
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
New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx
Age 18 or older and able to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing whether expiratory muscle strength training can help people with cancer of the head and neck who are undergoing radiation therapy or chemoradiotherapy to maintain efficient and safe swallowing function.
Who is the study for?
This trial is for adults over 18 with a new diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx who are about to undergo radiation therapy with or without chemotherapy. Participants must be able to use and maintain a seal on the EMST150 device. Those with prior head and neck surgery (except neck dissection), previous radiotherapy, non-HNCA related swallowing issues, progressive neurological conditions affecting muscle strength, or certain primary cancers are excluded.Check my eligibility
What is being tested?
The study tests whether expiratory muscle strength training (EMST) can help people with head and neck cancer maintain safe and efficient swallowing during their treatment with radiation therapy or chemoradiotherapy. It's a randomized trial where participants will either receive EMST or not by chance.See study design
What are the potential side effects?
While specific side effects of EMST aren't detailed here, general risks may include discomfort from using the device, fatigue from exercises, potential soreness in throat muscles due to training intensity, and possible exacerbation of existing swallowing difficulties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is newly diagnosed and located in my mouth or throat.
Select...
I am 18 or older and can give my consent.
Select...
I can use and hold the EMST150 device in my mouth properly.
Select...
I am scheduled for radiotherapy, with or without chemotherapy.
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
Feeding-tube-free food intake (days)
Secondary outcome measures
Extent of hyoid movement (mm)
Penetration-Aspiration Scale rating (number)
Presence of pharyngeal residue (dichotomous)
+2 moreOther outcome measures
Eating Assessment Tool (EAT-10) (number)
M.D. Anderson Dysphagia Inventory (MDADI) (number)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active EMST + Standard CareExperimental Treatment1 Intervention
Patients randomized to the Active EMST + Standard Care arm (ACTIVE) will use the EMST150 device as packaged, i.e. following package instructions with a device that has its valve spring maintained.
Group II: Sham EMST + Standard CarePlacebo Group1 Intervention
Those randomized to the Sham EMST + Standard Care arm (SHAM) will use an EMST150 device that has been modified by removing the internal spring, which allows the valve to open in response to airflow through the device regardless of the amount of pressure generated.
Find a Location
Who is running the clinical trial?
University of Wisconsin, MilwaukeeLead Sponsor
49 Previous Clinical Trials
6,603 Total Patients Enrolled
Froedtert HospitalOTHER
9 Previous Clinical Trials
10,686 Total Patients Enrolled
Medical College of WisconsinOTHER
610 Previous Clinical Trials
1,162,683 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swallowing difficulties not caused by head or neck cancer.I have had radiotherapy for head or neck cancer before.My cancer is newly diagnosed and located in my mouth or throat.I have had surgery on my head or neck, but a neck dissection is allowed.My cancer originated in the nasopharynx, sinuses, salivary glands, or skin.I am 18 or older and can give my consent.I have a condition like ALS or Parkinson's that is getting worse.I can use and hold the EMST150 device in my mouth properly.I am scheduled for radiotherapy, with or without chemotherapy.The origin of my cancer is unknown.
Research Study Groups:
This trial has the following groups:- Group 1: Active EMST + Standard Care
- Group 2: Sham EMST + Standard Care
Awards:
This trial has 0 awards, including: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.
Are there still opportunities for volunteers to participate in this research?
"Clinicaltrials.gov attests that this medical experiment is open to volunteers, having been first advertised on July 12th 2017 and most recently updated October 12th 2021."
Answered by AI
What is the current total of participants in this experiment?
"Affirmative. Clinicaltrials.gov has verified that this particular research is in search of 30 subjects at 1 site, with the initiative originally launching on July 12th 2017 and most recently revised October 12th 2021."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger