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

175 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if exercising the muscles that help you cough and swallow, called expiratory muscle strength training (EMST), can help reduce the risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients who have had radiation for head and neck cancer.

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 data supports the effectiveness of the treatment Expiratory Muscle Strength Training (EMST) Device for pneumonia risk after head and neck cancer treatment?

Research shows that Expiratory Muscle Strength Training (EMST) can improve swallowing function and airway safety in patients who have undergone radiation for nasopharyngeal carcinoma, suggesting it may help reduce pneumonia risk by strengthening the muscles involved in breathing and swallowing. ^{1 2 3 4 5}

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

Expiratory Muscle Strength Training (EMST) is generally considered safe for humans, as studies have shown it to be a safe and effective intervention for various conditions, including voice and swallowing disorders after head and neck cancer treatments. ^{3 4 6 7 8}

How is the Expiratory Muscle Strength Training (EMST) treatment different from other treatments for pneumonia risk after head and neck cancer treatment?

The Expiratory Muscle Strength Training (EMST) treatment is unique because it is a simple, device-driven exercise therapy that strengthens the muscles used for breathing out, which can help improve cough function and swallowing. Unlike other treatments, it is non-invasive, can be done at home, and specifically targets respiratory muscle strength to reduce aspiration risk, which is a common issue after head and neck cancer treatment. ^{3 4 7 8 9}

Research Team

Katherine A. Hutcheson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

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

Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. [2022]

2. Thailand pubmed.ncbi.nlm.nih.gov

Feasibility and Efficacy of Inspiratory Muscle Training in Patients with Head and Neck Cancer receiving Concurrent Chemoradiotherapy. [2022]

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

Improvement in Swallowing Function in Patients with Previous Irradiation for Nasopharyngeal Carcinoma by Expiratory Muscle Strength Training. [2023]

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

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

5. United States 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. [2021]

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

Examination of strength training and detraining effects in expiratory muscles. [2022]

7. 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]

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

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

9. England pubmed.ncbi.nlm.nih.gov

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