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 explores whether a special breathing exercise, called expiratory muscle strength training (EMST), can help people with head and neck cancer maintain safe swallowing during treatment. Participants will use either a regular EMST device or a modified version that requires no effort. The researchers aim to determine if the active device helps keep swallowing muscles functioning well. The trial seeks individuals recently diagnosed with head or neck cancer who are beginning radiation or chemotherapy and can use the EMST device. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance quality of life during cancer treatment.

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.

What prior data suggests that EMST is safe for swallowing disorders in head and neck cancer patients?

Research shows that expiratory muscle strength training (EMST) is generally safe for people with head and neck cancer. Studies have found that EMST strengthens swallowing muscles, improving swallowing for some patients.

In one study, seven out of 21 patients reported feeling safer after completing EMST, indicating a positive response to the treatment. No major reports of serious side effects from EMST have emerged.

Overall, the treatment is well-tolerated, with no significant negative effects reported in the studies. While more research is always beneficial, current evidence suggests EMST is safe for people with head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMST (Expiratory Muscle Strength Training) treatment for swallowing disorders in head and neck cancer patients because it offers a non-invasive approach that strengthens the muscles involved in swallowing. Unlike traditional treatments like surgery or medication, EMST uses a simple device that patients can use at home to improve their swallowing function by targeting and enhancing expiratory muscle strength. This method is unique because it empowers patients to take an active role in their rehabilitation, potentially leading to faster and more effective improvements in their ability to swallow safely. The treatment also minimizes the need for more invasive procedures, which can be a significant advantage for those recovering from cancer treatment.

What evidence suggests that EMST is effective for swallowing disorders in head and neck cancer patients?

Research has shown that expiratory muscle strength training (EMST) strengthens the muscles used for swallowing. In this trial, participants will be randomized into two groups: one receiving Active EMST + Standard Care and the other receiving Sham EMST + Standard Care. Studies have found that this training improves swallowing, which is crucial for head and neck cancer patients undergoing radiation therapy. Evidence suggests that EMST increases the strength of exhalation, aiding in safer swallowing. However, some reviews have reported mixed results on its effect on specific swallowing measures. Overall, EMST has effectively made swallowing safer and more efficient, offering hope for patients with swallowing difficulties. ^{2 3 5 6 7}

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

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11790605/

Effects of Expiratory Muscle Strength Training on Swallowing ... There is evidence that EMST causes activation and hypertrophy of the muscles of swallowing, with clinical evidence that it improves swallowing in certain ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03975465

EMST and Swallowing in Long-Term Survivors of HNCA This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related ...

3. theajo.com theajo.com/article/view/4798/html

Validation of SPECT-CT to assess improvement in airway ... Additionally, we tested the utility of an 8-week therapeutic period using the expiratory muscle strength training (EMST) device to improve ...

4. pubs.asha.org pubs.asha.org/doi/10.1044/2019_AJSLP-19-00107

Effects of Expiratory Muscle Strength Training on ... This review failed to find clear evidence regarding the effects of EMST on videofluoroscopic measures of swallowing.

5. rehab.research.va.gov rehab.research.va.gov/jour/2014/512/pdf/page305.pdf

Detraining outcomes with expiratory muscle strength ... Abstract—Expiratory muscle strength training (EMST) is efficacious for improving maximum expiratory pressure. (MEP), cough function, and swallowing safety ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5823707/

Expiratory Muscle Strength Training for Radiation ... Thus, the purpose of this case series was to examine the therapeutic potential of EMST among head and neck cancer (HNC) survivors with chronic radiation- ...

7. cuh.nhs.uk cuh.nhs.uk/patient-information/expiratory-muscle-strength-training-emst/

Expiratory muscle strength training (EMST) | CUH EMST is a rehabilitation approach which uses a device to exercise and increase the maximal pressure of the expiratory muscles.