EMST for Swallowing Disorders in Head and Neck Cancer Patients

Recruiting at 1 trial location

Overseen By Barbara Pauloski, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Milwaukee

Disqualifiers: Primary surgery, Unknown tumor, Neurologic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether a breathing exercise called Expiratory Muscle Strength Training (EMST) can help patients with head and neck cancer who are undergoing radiation therapy or chemoradiotherapy improve their swallowing. The exercise aims to make the muscles used for breathing out stronger, which may also help with swallowing. EMST is an intervention for patients with oropharyngeal dysphagia and has been proven effective in previous studies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Expiratory Muscle Strength Training (EMST) safe for humans?

Expiratory Muscle Strength Training (EMST) is generally considered safe for humans, as it is a simple, device-driven exercise therapy that can be performed at home and has been used in various patient groups, including those with voice and swallowing disorders. ^{1 2 3 4 5}

How is the treatment EMST different from other treatments for swallowing disorders in head and neck cancer patients?

Expiratory Muscle Strength Training (EMST) is unique because it is a simple, device-driven exercise therapy that strengthens the muscles involved in breathing and swallowing. Unlike other treatments, it can be performed at home and focuses on improving expiratory pressure, which may help with swallowing and cough function. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment EMST for swallowing disorders in head and neck cancer patients?

Research suggests that expiratory muscle strength training (EMST) can be a safe and effective treatment for improving swallowing and voice disorders in head and neck cancer patients, as well as enhancing cough function in various patient groups. ^{1 2 3 4 5}

Who Is on the Research Team?

Barbara Pauloski

Principal Investigator

University of Wisconsin, Milwaukee

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer is newly diagnosed and located in my mouth or throat.

I am 18 or older and can give my consent.

I can use and hold the EMST150 device in my mouth properly.

Exclusion Criteria

I have swallowing difficulties not caused by head or neck cancer.

I have had radiotherapy for head or neck cancer before.

I have had surgery on my head or neck, but a neck dissection is allowed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are evaluated prior to initiation of cancer treatment, including measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS), and administration of swallow-related quality of life (QOL) questionnaires

1 week

1 visit (in-person)

Treatment

Participants undergo an 8-week program of either Active or Sham Expiratory Muscle Strength Training (EMST) coincident with RT/CRT, with assessments at 4 weeks and 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in swallowing function and quality of life post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EMST

Trial Overview 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.

How Is the Trial Designed?

Group I: Active EMST + Standard Care Experimental Treatment 1 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 Care Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Milwaukee

Lead Sponsor

Trials

52

Recruited

6,200+

Froedtert Hospital

Collaborator

Trials

10

Recruited

10,700+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

In a study of 64 head and neck cancer survivors with chronic aspiration issues, 91% had reduced maximum expiratory pressures (MEPs), indicating a need for targeted therapy.

After 8 weeks of expiratory muscle strength training (EMST), participants showed a significant 57% improvement in MEPs and enhanced swallowing safety, suggesting EMST could be an effective intervention for improving airway protection in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory muscle strength training for radiation-associated aspiration after head and neck cancer: A case series. Hutcheson, KA., Barrow, MP., Plowman, EK., et al.[2019]

Expiratory muscle strength training (EMST) is a safe and effective home-based intervention for individuals with voice and swallowing disorders, showing positive results in a pilot study with 6 participants who had undergone supracricoid partial laryngectomy (SCPL).

Participants experienced a significant 21% increase in peak cough flow and a 38% reduction in dyspnea symptoms after a 4-week EMST program, indicating its potential benefits for respiratory function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Expiratory Muscle Strength Training for Rehabilitation After Supracricoid Partial Laryngectomy: A Pilot Investigation. Palmer, AD., Bolognone, RK., Thomsen, S., et al.[2022]

Expiratory muscle strength training (EMST) is feasible and safe for individuals who have undergone total laryngectomy, with high compliance observed among participants in the study.

While EMST led to improvements in maximum expiratory pressure and vocal loudness, it did not result in significant changes in other pulmonary function or patient-reported outcomes, suggesting further research is needed in a larger group with more pronounced pulmonary issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study. van Sluis, KE., Kornman, AF., Groen, WG., et al.[2022]

The Elevation Training Mask 2.0® (ETM) offers adjustable expiratory muscle strength resistance pressures, making it a potential alternative to traditional EMST devices for treating swallowing dysfunction.

Current results indicate that while the ETM provides lower resistance compared to the EMST150, it may still be effective for respiratory muscle strength training, warranting further research on its safety and clinical efficacy in patients with swallowing disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High elevation training mask as a respiratory muscle strength training tool for dysphagia. Shen, SC., Nachalon, Y., Randall, DR., et al.[2019]

A systematic review of 11 studies on expiratory muscle strength training (EMST) for dysphagia showed mixed results regarding its effectiveness on swallowing function, highlighting the need for more standardized measures.

The review noted significant variability in study protocols and patient populations, which complicated the ability to draw clear conclusions about EMST's impact on swallowing as assessed by videofluoroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Expiratory Muscle Strength Training on Videofluoroscopic Measures of Swallowing: A Systematic Review. Mancopes, R., Smaoui, S., Steele, CM.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Expiratory muscle strength training for radiation-associated aspiration after head and neck cancer: A case series. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Expiratory Muscle Strength Training for Rehabilitation After Supracricoid Partial Laryngectomy: A Pilot Investigation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

High elevation training mask as a respiratory muscle strength training tool for dysphagia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Expiratory Muscle Strength Training on Videofluoroscopic Measures of Swallowing: A Systematic Review. [2021]