Clinical trial NCT03916809: EMST in Patients Undergoing CRT for HNCA
Official title: Impact of Expiratory Muscle Strength Training (EMST) on Swallowing Function in Persons Undergoing Radiotherapy With or Without Chemotherapy (CRT) for Cancers of the Head and Neck (HNCA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Deglutition Disorders
Keywords: oropharyngeal cancer
laryngeal cancer
swallow
chemoradiation
expiratory muscle strength training
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: Froedtert Hospital
name: Medical College of Wisconsin
First posted: 2019-04-16
Enrollment: 30
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 Active Expiratory Muscle Strength Training (EMST) + Standard Care or Sham EMST + 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 maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT/CRT).

Detailed description: Thirty (30) persons with newly-diagnosed HNCA who will be treated with RT/CRT will be randomized to an 8-week program of either Active Expiratory Muscle Strength Training (EMST) + Standard Care or Sham EMST + Standard Care in order to examine the impact of EMST on swallowing function. The training program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks, coincident with RT/CRT. Patients randomized to the Active EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Those randomized to the Sham EMST group will use an EMST150 device that has been modified to eliminate resistance to airflow.

All subjects will be evaluated prior to initiation of cancer treatment (baseline assessment), 4 weeks into cancer treatment and again at the completion of cancer treatment (8 weeks after initiation of treatment). Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, and administration of swallow-related quality of life (QOL) questionnaires.

Eligibility criteria: Inclusion Criteria:

* New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx;
* Planned treatment with primary radiotherapy with or without chemotherapy;
* Age 18 or older and able to provide consent;
* Ability to use the EMST150 device (hold in mouth and maintain lip seal)

Exclusion Criteria:

* Primary surgery to the head and neck (neck dissection is permitted);
* Unknown primary tumor;
* Primary cancers of the nasopharynx, paranasal sinuses, salivary glands and skin.
* Progressive neurologic condition affecting muscle strength (e.g. amyotrophic lateral sclerosis (ALS), Parkinson's disease)
* Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke or post--traumatic brain injury (TBI))
* Prior history of head and neck radiotherapy

Primary outcomes:
measure: Feeding-tube-free food intake (days)
timeFrame: 8 weeks
Secondary outcomes:
measure: Penetration-Aspiration Scale rating (number)
timeFrame: 8 weeks
measure: Timing of Aspiration (category)
timeFrame: 8 weeks
measure: Presence of pharyngeal residue (dichotomous)
timeFrame: 8 weeks
measure: Extent of hyoid movement (mm)
timeFrame: 8 weeks
measure: Upper esophageal sphincter (UES) opening width (mm)
timeFrame: 8 weeks
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
role: PRINCIPAL_INVESTIGATOR
References: