Actively Recruiting
Impact of Expiratory Muscle Strength Training (EMST) on Swallowing Function in Persons Undergoing Radiotherapy With or Without Chemotherapy for Head and Neck Cancers
Led by University of Wisconsin, Milwaukee · Updated on 2024-12-04
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Wisconsin, Milwaukee
Lead Sponsor
F
Froedtert Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of expiratory muscle strength training (EMST) on maintaining safe and effective swallowing in people with newly diagnosed head and neck cancer undergoing radiation therapy or chemoradiotherapy. This study is a randomized trial involving 30 participants to compare the effects of active EMST versus a sham training program alongside standard care. The focus is on how EMST may help preserve swallowing function during cancer treatment. Participants will be randomly assigned to one of two groups for an 8-week training program during their cancer treatment. One group will perform active EMST using the EMST150 device according to instructions, while the other group will use a modified sham device that removes resistance to airflow. The training involves 5 sets of 5 breaths, 5 days per week, coinciding with radiation or chemoradiotherapy. Both groups will continue to receive standard care for their cancer. Participants will undergo assessments before starting cancer treatment, at 4 weeks into treatment, and at 8 weeks (treatment completion). Evaluations include measuring maximum expiratory pressure, videofluoroscopic swallow studies to observe swallowing function, and swallow-related quality of life questionnaires. The main outcome measured is the number of days participants can eat without a feeding tube after 8 weeks. Other swallowing function aspects such as aspiration risk and muscle movement will also be evaluated.
CONDITIONS
Brief Title
EMST in Patients Undergoing CRT for HNCA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx
- Planned treatment with primary radiotherapy with or without chemotherapy
- Age 18 or older and able to provide consent
- Ability to use the EMST150 device by holding it in mouth and maintaining a lip seal
You will not qualify if you...
- Primary surgery to the head and neck (neck dissection is permitted)
- Unknown primary tumor
- Primary cancers of the nasopharynx, paranasal sinuses, salivary glands, and skin
- Progressive neurologic condition affecting muscle strength (e.g., ALS, Parkinson's disease)
- Dysphagia not related to head and neck cancer (e.g., unresolved swallowing difficulty post-stroke or traumatic brain injury)
- Prior history of head and neck radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants undergo an 8-week program of either Active Expiratory Muscle Strength Training (EMST) or Sham EMST alongside their radiotherapy with or without chemotherapy for head and neck cancers.
1 baseline visit, 1 visit at 4 weeks, and 1 visit at 8 weeks
Trial Site Locations
Total: 2 locations
1
University of Wisconsin Milwaukee
Milwaukee, Wisconsin, United States, 53211
Active, Not Recruiting
2
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
B
Barbara Pauloski, Ph.D.
S
Stephanie Stevens, M.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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