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

N/A

Waitlist Available

Led By Katherine A. Hutcheson, PHD, MS, BA

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of curative-intent radiotherapy at MDACC for a new primary H&N cancer in past 15 years

Age >/= 18 years

Must not have

History of functionally limiting chronic or acute cardiac, pulmonary, or neuromuscular disease

History of recurrent or second primary H&N, central nervous system, or thoracic cancer at time of modified barium swallow (MBS) study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if exercising the muscles involved in coughing and swallowing can help reduce the risk of pneumonia for patients who have had radiation for head and neck cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from using the EMST device or during the barium swallow test. Neurocognitive exams pose no physical risks but may cause stress or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had surgery for head and neck cancer, but not just for diagnosis or minor procedures.

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I need a tracheotomy or oxygen to breathe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Association Between Aspiration and Expiratory Function Using Expiratory Training in Post-Radiotherapy H&N Cancer Survivors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Non-Aspirators GroupExperimental Treatment4 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 GroupExperimental Treatment6 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Barium

2015

N/A

~900

Questionnaires

2013

Completed Phase 2

~4280