EMST in Patients Undergoing CRT for HNCA

Head and Neck Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916809
• Other study ID #: PRO29168
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2023
• Source: University of Wisconsin, Milwaukee
• Contact: Barbara Pauloski, Ph.D.
• Phone: 4142296719
• Email: pauloski[@]uwm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Wisconsin Milwaukee	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	Froedtert Hospital, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eating Assessment Tool (EAT-10) (number)	Change in score on the EAT-10 will be calculated from baseline to mid-treatment to post-treatment. EAT-10 is an ordinal rating scale with values that range from 0 to 40, with lower score reflecting better function.	8 weeks
Other	M.D. Anderson Dysphagia Inventory (MDADI) (number)	Change in scores on the M.D. Anderson Dysphagia Inventory (MDADI) will be calculated from baseline to mid-treatment to post-treatment. MDADI consists of four ordinal rating scales with scores ranging from 0 to 100 with higher score reflecting better function.	8 weeks
Primary	Feeding-tube-free food intake (days)	the number of days from the beginning of the study until change in feeding status from 100% oral intake to combined oral intake and tube intake and/or 100% tube feeding will be calculated	8 weeks
Secondary	Penetration-Aspiration Scale rating (number)	From Videofluoroscopic Swallow Studies (VFSS), change in Penetration-Aspiration scale score will be determined from baseline to mid-treatment to post-treatment. Penetration-Aspiration Scale is an 8-point ordinal rating scale.	8 weeks
Secondary	Timing of Aspiration (category)	From Videofluoroscopic Swallow Studies (VFSS), timing of aspiration will be determined from baseline to mid-treatment to post-treatment. Timing is identified as a category, either before, during, or after.	8 weeks
Secondary	Presence of pharyngeal residue (dichotomous)	From Videofluoroscopic Swallow Studies (VFSS), the presence of residue in the pharynx (yes or no) will be determined from baseline to mid-treatment to post-treatment.	8 weeks
Secondary	Extent of hyoid movement (mm)	From Videofluoroscopic Swallow Studies (VFSS), the change in extent of hyoid movement in mm will be determined from baseline to mid-treatment to post-treatment.	8 weeks
Secondary	Upper esophageal sphincter (UES) opening width (mm)	From Videofluoroscopic Swallow Studies (VFSS), the change in width of UES opening width in mm will be determined from baseline to mid-treatment to post-treatment.	8 weeks