Cough and Expiratory Training for Pneumonia Risk after Head and Neck Cancer Treatment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Recurrent cancer, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a special exercise using an expiratory muscle strength training (EMST) device can reduce pneumonia risk in individuals who have received radiation treatment for head and neck cancer. The exercise strengthens the muscles involved in coughing and swallowing, aiming to prevent saliva from entering the lungs. One group of participants will use the device at home, while another group will not. Individuals who have undergone radiation for head and neck cancer in the past 15 years and have been referred for a swallowing evaluation may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Expiratory Muscle Strength Training (EMST) device is safe for reducing pneumonia risk?

Research has shown that the Expiratory Muscle Strength Training (EMST) device is safe for use. The FDA has approved the device for aiding coughing and swallowing, indicating it has undergone safety testing. Studies have found that most people tolerate EMST well, with no major reports of serious side effects. Participants in these studies did not experience significant negative effects. This suggests that EMST is a safe choice for those seeking to prevent inhaling saliva instead of swallowing it after radiation treatment for head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores Expiratory Muscle Strength Training (EMST) as a novel approach to reducing pneumonia risk after head and neck cancer treatment. Unlike traditional methods that primarily focus on medication or surgery, EMST is a non-invasive technique that uses a special device to strengthen the muscles involved in breathing and coughing. This method is unique because it empowers patients to actively engage in their recovery at home, potentially improving lung function and quality of life with a simple 5-5-5 schedule of exercises. By enhancing the body's natural ability to clear the airway, EMST could offer a promising alternative for managing post-treatment pneumonia risk, an exciting possibility for both patients and healthcare providers.

What evidence suggests that the EMST device is effective for reducing pneumonia risk after head and neck cancer treatment?

Research shows that the Expiratory Muscle Strength Training (EMST) device strengthens the muscles used for coughing and swallowing. Studies have found that this device may help prevent inhaling saliva instead of swallowing it, particularly in individuals who have undergone radiation treatment for head and neck cancer. In this trial, participants in the Aspirators Group will use the EMST device for an 8-week training program, which has improved breathing functions and lowered the risk of pneumonia. This device is considered safe and effective for various conditions, including those faced by head and neck cancer patients. Overall, evidence suggests that EMST can be a promising tool in reducing the risk of pneumonia after cancer treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Katherine A. Hutcheson

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults who've had radiation therapy at MDACC for new primary head and neck cancer within the last 15 years, need a swallowing evaluation, can consent to participate, and have no history of certain surgeries or recurrent cancers. Those with severe cognitive impairment, tracheotomy, oxygen dependence, or major heart/lung/muscle diseases cannot join.

Inclusion Criteria

Ability to understand and willingness to sign written informed consent

I had radiotherapy aimed at curing a new head or neck cancer within the last 15 years.

I have been referred for a swallowing check by a speech or hearing specialist.

Exclusion Criteria

I have a chronic or acute heart, lung, or muscle disease that limits my activities.

Patients with Mini-Mental State Examination (MMSE) <24 will be ineligible for participation in the therapeutic trial

I have had head, neck, brain, or chest cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the EMST device at home on a 5-5-5 schedule for 8 weeks, with weekly visits to adjust device resistance and measure expiratory function.

8 weeks

8 visits (in-person)

Follow-up Visit

Participants undergo functional testing and complete questionnaires about symptoms and quality of life.

1 visit

1 visit (in-person)

Follow-up Call

Participants are contacted by phone to complete questionnaires about symptoms, health, and quality of life.

12 months after study start

1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Expiratory Muscle Strength Training (EMST) Device

Trial Overview

The study tests if expiratory muscle strength training (EMST) reduces pneumonia risk from aspiration after radiotherapy for head and neck cancer. It involves exercises using an EMST device alongside evaluations like barium swallows, questionnaires, digital manometer readings, and neurocognitive exams.

How Is the Trial Designed?

Group I: Non-Aspirators Group Experimental Treatment 4 Interventions

Participants receive modified barium swallow at baseline. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline and at 12 months.

Group II: Aspirators Group Experimental Treatment 6 Interventions

Participants receive modified barium swallow at baseline and after 8 weeks of using the expiratory muscle strength training (EMST) device. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study. Participant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks. Digital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

IRG

Collaborator

Trials

1

Recruited

180+

Published Research Related to This Trial

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]

In a study involving 240 head and neck cancer patients, early initiation of swallowing exercises and progressive resistance training during radiotherapy showed significant improvements in quality of life, depression, and anxiety at the 12-month follow-up compared to usual care.

However, the intervention did not significantly improve swallowing safety, indicating that while the exercises may enhance overall well-being, they may not directly address swallowing function in patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. Hajdú, SF., Wessel, I., Dalton, SO., et al.[2022]

A 12-week strength training program, including novel strength training (NST) with eccentric overload and neuromuscular electrical stimulation (NMES), was feasible for head and neck cancer patients, showing high completion (100% NST, 82% CST) and adherence rates (92% NST, 81% CST).

Both NST and conventional strength training significantly improved muscle strength, muscle size, and health-related quality of life, suggesting that these interventions can effectively aid recovery after head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of eccentric overloading and neuromuscular electrical stimulation to improve muscle strength and muscle mass after treatment for head and neck cancer. Lavigne, C., Twomey, R., Lau, H., et al.[2021]

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]

Participants in an expiratory muscle strength training (EMST) program showed significant strength gains, with a 41% increase after 4 weeks and a 51% increase after 8 weeks, indicating that EMST is effective for improving expiratory muscle strength.

After an 8-week detraining period, participants maintained significantly higher expiratory muscle strength compared to baseline, suggesting that the benefits of EMST persist even after training stops, regardless of the training duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of strength training and detraining effects in expiratory muscles. Baker, S., Davenport, P., Sapienza, C.[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]

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]

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