Clinical trial NCT03975465: EMST and Swallowing in Long-Term Survivors of HNCA
Official title: Effects of Expiratory Muscle Strength Training (EMST) on Long-Term Swallowing Dysfunction in Persons With Head and Neck Cancer (HNCA) Post Irradiation (RT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Neoplasms
Deglutition Disorders
Keywords: oropharyngeal cancer
laryngeal cancer
swallow
chemoradiation
expiratory muscle strength training
long-term survivor
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: Froedtert Hospital
name: Medical College of Wisconsin
First posted: 2019-06-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to an 8-week program of either Expiratory Muscle Strength Training (EMST) or Standard Care in order to examine the impact of EMST on swallowing function
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Twenty (20) persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously will be randomized to an 8-week program of either EMST only and Standard Care only in order to examine the impact of EMST on swallowing function. The EMST program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks at 75% of maximum expiratory strength. Patients randomized to the EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Standard Care will include swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion. Subjects will be instructed to practice these exercises following a progressive protocol 5 days per week for 8 weeks.

All subjects will be evaluated at baseline and at the completion of their rehabilitation program. Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, administration of swallow-related quality of life (QOL) questionnaires, and documentation of current diet using the International Dysphagia Diet Standardisation Initiative (IDDSI) Drink Levels and Food Levels.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. 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;
3. Ability to follow directions and engage in a program of rehabilitation

Exclusion Criteria:

1. the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);
2. 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.

Primary outcomes:
measure: Level of Oral Intake (number)
timeFrame: 8 weeks
measure: Maximum Expiratory Pressure (MEP) cm H20
timeFrame: 8 weeks
measure: Extent of hyoid movement (mm)
timeFrame: 8 weeks
measure: Upper esophageal sphincter (UES) opening width (mm)
timeFrame: 8 weeks
measure: Presence of pharyngeal residue (dichotomous)
timeFrame: 8 weeks
measure: Penetration-Aspiration Scale rating (number)
timeFrame: 8 weeks
measure: Timing of Aspiration (category)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
measure: Eating Assessment Tool (EAT-10) (number)
timeFrame: 8 weeks
measure: M.D. Anderson Dysphagia Inventory (MDADI) (number)
timeFrame: 8 weeks
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Barbara Pauloski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: