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)

Overview

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.

Interventions

• Other EMST
  Expiratory muscle strength training (EMST) is an exercise program designed to strengthen the muscles of expiration by increasing expiratory load during breathing exercises using either resistive or pressure threshold devices. The EMST150 is a commercially-available device considered non-significant risk (NSR). The EMST150 device will be used for this study.

Primary outcome measures

• Feeding-tube-free food intake (days) [Time frame: 8 weeks]

Secondary outcome measures (5)

• Penetration-Aspiration Scale rating (number) [Time frame: 8 weeks]
• Timing of Aspiration (category) [Time frame: 8 weeks]
• Presence of pharyngeal residue (dichotomous) [Time frame: 8 weeks]
• Extent of hyoid movement (mm) [Time frame: 8 weeks]
• Upper esophageal sphincter (UES) opening width (mm) [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• University of Wisconsin Milwaukee — Milwaukee
• Froedtert Hospital — Milwaukee

Identifiers

NCT: NCT03916809 · PRO29168

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗