TerminatedNot Applicable

EMST and Swallowing in Long-Term Survivors of HNCA

Stopped: Poor accruals

United States6 participantsStarted 2018-09-10

Plain-language summary

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx, or for an unknown primary at least 5 years prior to enrollment. Subjects may have had surgery as long as a minimum dose of 50 Gy of radiation was part of the treatment;
. Subject must have a current swallow complaint or impairment; these include but are not limited to reduced oral intake, perceived difficulty with bolus transport (e.g. feeling of food sticking in throat); aspiration on various bolus consistencies;
. Ability to follow directions and engage in a program of rehabilitation

Exclusion criteria

. the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);
. the subject presents with contraindications for EMST as specified in the EMST150 package insert unless cleared for participation by the subject's physician. These conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of Oral Intake (number)

Timeframe: 8 weeks

Maximum Expiratory Pressure (MEP) cm H20

Timeframe: 8 weeks

Extent of hyoid movement (mm)

Timeframe: 8 weeks

Upper esophageal sphincter (UES) opening width (mm)

Timeframe: 8 weeks

Presence of pharyngeal residue (dichotomous)

Timeframe: 8 weeks

Penetration-Aspiration Scale rating (number)

Timeframe: 8 weeks

Timing of Aspiration (category)

Timeframe: 8 weeks

Trial details

NCT IDNCT03975465

SponsorUniversity of Wisconsin, Milwaukee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-04

View on ClinicalTrials.gov More Head and Neck Neoplasms trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx, or for an unknown primary at least 5 years prior to enrollment. Subjects may have had surgery as long as a minimum dose of 50 Gy of radiation was part of the treatment;
. Subject must have a current swallow complaint or impairment; these include but are not limited to reduced oral intake, perceived difficulty with bolus transport (e.g. feeling of food sticking in throat); aspiration on various bolus consistencies;
. Ability to follow directions and engage in a program of rehabilitation

Exclusion criteria

. the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);
. the subject presents with contraindications for EMST as specified in the EMST150 package insert unless cleared for participation by the subject's physician. These conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.

What they're measuring

Level of Oral Intake (number)

Timeframe: 8 weeks

Maximum Expiratory Pressure (MEP) cm H20

Timeframe: 8 weeks

Extent of hyoid movement (mm)

Timeframe: 8 weeks

Upper esophageal sphincter (UES) opening width (mm)

Timeframe: 8 weeks

Presence of pharyngeal residue (dichotomous)

Timeframe: 8 weeks

Penetration-Aspiration Scale rating (number)

Timeframe: 8 weeks

Timing of Aspiration (category)

Timeframe: 8 weeks