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

Overseen by Katherine A. Hutcheson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

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.

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.

Treatment Details

Interventions

• Expiratory Muscle Strength Training (EMST) Device (Behavioral Intervention)

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+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

IRG

Collaborator

Trials

1

Recruited

180+