search
Back to results

Effects of Expiratory Muscle Strength Training on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy

Primary Purpose

Cancer of the Head and Neck

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Expiratory Muscle Strength Training (EMST)
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Head and Neck

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Chronic dysphagia involving the pharyngeal phase of swallowing for at least 6 months
  • Undergone radiation therapy for head and neck cancer
  • Penetration and/or aspiration seen on previous clinical videofluoroscopy swallow study (Penetration-Aspiration Scale score of 2 to 8)
  • Failure to respond to traditional dysphagia therapy, as indicated by no improvement or only an improvement of 1 point on the Functional Oral Intake Scale, over a period of at least 4 sessions of conventional dysphagia therapy.

Exclusion criteria

  • Current pneumothorax
  • Severe trismus impeding insertion of rubber mouthpiece into the mouth (as part of treatment protocol)

Patients who have "perforated tympanic membrane", "history of spontaneous pneumothorax" and "history of collapsed lung", will be considered on a case-by-case basis, depending on the stability of their condition. Permission from their primary team doctors, or ENT for tympanic membrane issues, will be sought prior to enrolment into the study. These participants will only be deemed suitable for the study if their primary team doctors, ENT or respiratory doctors agree that they are stable or fully recovered, and that doing EMST will not worsen these conditions. For these patient groups, permission from the patients' primary team doctors, ENT or Respiratory Doctors will be obtained via email. Participants will not be enrolled if there is no written consent indicating approval for subject to be enrolled.

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Expiratory Muscle Strength Training (EMST)

Arm Description

Participants will be taught how to use the EMST-150 device. The device has a one-way spring-loaded valve calibrated at different resistances that the user can select. The valve will open when expiratory pressure exceeds the threshold set by the user on the device. This threshold is set at 75% of the individual's maximum expiratory pressure for the session.

Outcomes

Primary Outcome Measures

Maximum expiratory pressure
cm H2O
Change in Penetration Aspiration Scale score
An 8-point rating scale of the severity of penetration and aspiration events

Secondary Outcome Measures

Functional Oral Intake Scale
A 7-point scale looking at the normalcy of diet consistencies taken by the patient. The lowest score is 1 (No oral intake) and the maximum score is 7 (total oral intake with no restrictions).
Performance Status Scale-Head and Neck
An oral intake scale looking at the normalcy of diet consistencies taken by the patient. The scale ranges from 0 (tube-feeding) to 100 (full diet with no restrictions), in increments of 10.
MD Anderson Dysphagia Inventory
Self-reported swallowing-related quality of life
Modified Barium Swallow Impairment Profile
Seventeen components of swallowing are visually rated on video recordings of the modified barium swallow procedure.

Full Information

First Posted
July 9, 2018
Last Updated
March 25, 2020
Sponsor
Singapore General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03620084
Brief Title
Effects of Expiratory Muscle Strength Training on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy
Official Title
The Effects of Expiratory Muscle Strength Training (EMST) on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Radiation therapy for head and neck cancer (HNC) is associated with the development of swallowing difficulties, or dysphagia. Dysphagia has profound negative effects on the health, nutritional status, and quality of life of HNC survivors. It also puts them at risk of developing life-threatening aspiration pneumonia. Radiation-associated dysphagia can be intractable and not responsive to conventional dysphagia therapy. HNC survivors with chronic severe dysphagia may be dependent on long-term tube feeding. Expiratory Muscle Strength Training (EMST) is a low-cost, device-driven therapy. It has been studied as an approach to simultaneously improve cough and swallowing functions. During EMST, patients forcefully expire into a one-way spring-loaded valve to strengthen expiratory and submental musculature. The EMST-150 device is available for clinical use in Singapore. In other research studies, it has been shown to improve cough and swallowing in several populations of people with chronic dysphagia, most recently in people with chronic radiation-associated dysphagia. The investigators propose to study the effect of EMST using the EMST-150 device on cough, airway protection, and swallowing functions of HNC survivors with radiation-associated dysphagia. The investigators will recruit 40 participants to undergo an 8-week EMST programme, with weekly follow-up to calibrate their EMST device. It is hypothesised that EMST will improve participants' respiratory and swallowing functions. Respiratory function improvement will be shown by increased maximum expiratory pressure and improved cough airflow measures. Swallowing function improvement will be evidenced by reduced aspiration or improved ability to clear aspirated material during videofluoroscopic swallow studies. The investigators also hypothesize carryover effects on other aspects of swallowing, such as improved hyoid and laryngeal excursions, and improved laryngeal vestibule closure. With the results of this study, the investigators aim to develop better evidence-based rehabilitation programmes for HNC survivors, and those living with chronic dysphagia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expiratory Muscle Strength Training (EMST)
Arm Type
Experimental
Arm Description
Participants will be taught how to use the EMST-150 device. The device has a one-way spring-loaded valve calibrated at different resistances that the user can select. The valve will open when expiratory pressure exceeds the threshold set by the user on the device. This threshold is set at 75% of the individual's maximum expiratory pressure for the session.
Intervention Type
Device
Intervention Name(s)
Expiratory Muscle Strength Training (EMST)
Other Intervention Name(s)
EMST 150
Intervention Description
The target home practice frequency on the EMST-150 is: 5 repetitions of forceful expiration each time, 5 times daily, 5 days a week for 8 weeks, following the training protocol used by Hutcheson et al. (2017).
Primary Outcome Measure Information:
Title
Maximum expiratory pressure
Description
cm H2O
Time Frame
up to 8-week intervention
Title
Change in Penetration Aspiration Scale score
Description
An 8-point rating scale of the severity of penetration and aspiration events
Time Frame
At baseline and end of 8-week intervention
Secondary Outcome Measure Information:
Title
Functional Oral Intake Scale
Description
A 7-point scale looking at the normalcy of diet consistencies taken by the patient. The lowest score is 1 (No oral intake) and the maximum score is 7 (total oral intake with no restrictions).
Time Frame
At baseline and end of 8-week intervention
Title
Performance Status Scale-Head and Neck
Description
An oral intake scale looking at the normalcy of diet consistencies taken by the patient. The scale ranges from 0 (tube-feeding) to 100 (full diet with no restrictions), in increments of 10.
Time Frame
At baseline and end of 8-week intervention
Title
MD Anderson Dysphagia Inventory
Description
Self-reported swallowing-related quality of life
Time Frame
At baseline and end of 8-week intervention
Title
Modified Barium Swallow Impairment Profile
Description
Seventeen components of swallowing are visually rated on video recordings of the modified barium swallow procedure.
Time Frame
At baseline and end of 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Chronic dysphagia involving the pharyngeal phase of swallowing for at least 6 months Undergone radiation therapy for head and neck cancer Penetration and/or aspiration seen on previous clinical videofluoroscopy swallow study (Penetration-Aspiration Scale score of 2 to 8) Failure to respond to traditional dysphagia therapy, as indicated by no improvement or only an improvement of 1 point on the Functional Oral Intake Scale, over a period of at least 4 sessions of conventional dysphagia therapy. Exclusion criteria Current pneumothorax Severe trismus impeding insertion of rubber mouthpiece into the mouth (as part of treatment protocol) Patients who have "perforated tympanic membrane", "history of spontaneous pneumothorax" and "history of collapsed lung", will be considered on a case-by-case basis, depending on the stability of their condition. Permission from their primary team doctors, or ENT for tympanic membrane issues, will be sought prior to enrolment into the study. These participants will only be deemed suitable for the study if their primary team doctors, ENT or respiratory doctors agree that they are stable or fully recovered, and that doing EMST will not worsen these conditions. For these patient groups, permission from the patients' primary team doctors, ENT or Respiratory Doctors will be obtained via email. Participants will not be enrolled if there is no written consent indicating approval for subject to be enrolled.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Shan Lee, BSc
Phone
(65)63265481
Email
lee.yan.shan@sgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Shan Lee, BSc
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Shan Lee, BSpPath
Email
lee.yan.shan@sgh.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Expiratory Muscle Strength Training on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy

We'll reach out to this number within 24 hrs