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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

~3330

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,969 Previous Clinical Trials

1,786,730 Total Patients Enrolled

IRGUNKNOWN

Katherine A. Hutcheson, PHD, MS, BAPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Expiratory Muscle Strength Training (EMST) Device Clinical Trial Eligibility Overview. Trial Name: NCT02662907 — N/A

Head and Neck Cancers Research Study Groups: Aspirators Group, Non-Aspirators Group

Head and Neck Cancers Clinical Trial 2023: Expiratory Muscle Strength Training (EMST) Device Highlights & Side Effects. Trial Name: NCT02662907 — N/A

Expiratory Muscle Strength Training (EMST) Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT02662907 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this investigation?

"At the moment, this particular trial is not actively recruiting. The study was initially listed on February 1st 2016 and its most recent update occurred on October 20th 2022. If you're looking for other studies to join, there are currently 482 trials searching for patients with head and neck cancer as well as one that requires participants to use an Expiratory Muscle Strength Training Device."

Answered by AI

Is recruitment currently ongoing for this investigation?

"The clinicaltrials.gov records indicate that this trial is not enrolling patients currently - the last update was from October 20th 2022, shortly after it's initial posting on February 1st 2016. Despite this inactive status, there are still 483 other trials actively recruiting new participants."

Answered by AI

Have prior studies employed the Expiratory Muscle Strength Training (EMST) Device?

"Presently, 1 active research projects are studying the effects of Expiratory Muscle Strength Training (EMST) Device with none in Phase 3. Most studies for this device take place within Houston, Texas; however there is one other medical facility conducting such inquiries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy

2016. "Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02662907.

All > Head And Neck Cancer