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 range18 Years

SexALL

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

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 range18 Years

SexALL

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