Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001046594p
Ethics application status
Submitted, not yet approved
Date submitted
7/08/2024
Date registered
29/08/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Expiratory Muscle Strength Training in Head and Neck Cancer Survivors with Dysphagia: A Pilot Study
Scientific title
Effect of Expiratory Muscle Strength Training on Maximum Expiratory Pressure, Swallow Safety and Voice Function in Head and Neck Cancer Survivors with Dysphagia: A Pilot Study
Secondary ID [1] 312698 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 334721 0
Dysphonia 334722 0
Head and Neck Cancer 334731 0
Condition category
Condition code
Respiratory 331282 331282 0 0
Normal development and function of the respiratory system
Physical Medicine / Rehabilitation 331283 331283 0 0
Speech therapy
Diet and Nutrition 331284 331284 0 0
Other diet and nutrition disorders
Cancer 331415 331415 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description:
The Expiratory Muscle Strength Training device (EMST150) is a one-way, adjustable spring-loaded valve that creates resistance against expiration. Its objective is to train the muscles required for exhalation, improving their capacity for coughing and swallowing.

Dose and Duration:
To use the hand-held device, patients take a deep breath and blow forcefully into the mouthpiece 5 times, 5 times a day, 5 days a week, for 5 weeks. Using the rotating knob, the device is calibrated to the optimum resistance for training, which is 75% of the patient’s maximum expiratory pressure.
No other speech pathology interventions will be provided during the 5-week period.

Mode of Delivery:
EMST is a speech pathology led intervention. The therapy program begins with a 1-hour in-person outpatient appointment with the speech pathologist, whereby baseline swallow and voice function measures are collected. Then, the EMST150 device is calibrated to the optimum training resistance by the speech pathologist and the participant is taught how to use the device.
After initial consultation, the participant completes the training in their home, and the speech pathologist provides weekly 15-minute telehealth appointments to recalibrate the device as necessary and ensure adherence to the training program.
At the completion of the 5-week therapy program, participants attend a 1-hour in-person outpatient speech pathology appointment to repeat swallow and voice function measures and establish a maintenance program.

Materials: Prior to commencing the therapy program, patients will be provided with
- Patient information sheet outlining the aims of the proposed project and any risks or contraindications for use of the EMST150 device.
- The EMST150 device and instructions manual
- Adherence diary
Intervention code [1] 329227 0
Treatment: Devices
Comparator / control treatment
The study design is a prospective interventional pre-post pilot study assessing primary and secondary outcomes of laryngeal function as it relates to swallowing and voice. Participants will be their own control – meaning limiting factors such as diversity in this population will be minimised.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339040 0
Maximum Expiratory Pressure (MEP)
Timepoint [1] 339040 0
Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
Secondary outcome [1] 438334 0
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
Timepoint [1] 438334 0
Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
Secondary outcome [2] 438335 0
MD Anderson Dysphagia Inventory (MDADI)
Timepoint [2] 438335 0
Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
Secondary outcome [3] 438336 0
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Timepoint [3] 438336 0
Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
Secondary outcome [4] 438337 0
Voice Handicap Index-10 (VHI-10)
Timepoint [4] 438337 0
Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
Secondary outcome [5] 438338 0
False Vocal Fold (FVF) Behaviour
Timepoint [5] 438338 0
Immediately pre-intervention (week 1) and immediately post-intervention (week 5).

Eligibility
Key inclusion criteria
Adult head and neck cancer survivors (age 18 years and over) who have completed treatment (surgery and or chemoradiotherapy) greater than 3 months ago (to exclude treatment effect) with associated dysphagia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with physical, language or cognitive barriers unable to perform or tolerate EMST and Flexible Nasendoscopy.
• Patients who are currently undergoing treatment for HNC.
• Patients where EMST is contraindicated, i.e. where the treating physician does not endorse the intervention, respiratory and cardiothoracic comorbidities, hypertension.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcomes collected from the primary and secondary measurements will be analysed and descriptively reported. Through collaboration with the Dr Liang Voice Program, the research team has access to a statistician who will assist with this component of the study.

We aim to have 37 participants partake in the study to determine the correlation between EMST and the primary and secondary outcomes with a precision of 0.5. However, due to the nature of the recruitment method, the final number of participants may differ.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
26/05/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
37
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26906 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 42968 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 317131 0
Other
Name [1] 317131 0
Central Adelaide Local Health Network Allied and Scientific Health Research Grant 2024-2025 Stream 1: Acraman Bequest
Country [1] 317131 0
Australia
Primary sponsor type
Other
Name
Central Adelaide Local Health Network Speech Pathology Department
Address
Country
Australia
Secondary sponsor category [1] 319396 0
None
Name [1] 319396 0
Address [1] 319396 0
Country [1] 319396 0
Other collaborator category [1] 283128 0
University
Name [1] 283128 0
Dr Liang Voice Program, The University of Sydney
Address [1] 283128 0
Country [1] 283128 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315882 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315882 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 315882 0
Australia
Date submitted for ethics approval [1] 315882 0
08/08/2024
Approval date [1] 315882 0
Ethics approval number [1] 315882 0

Summary
Brief summary
This study will investigate the effect of Expiratory Muscle Strength Training (EMST) on Maximum Expiratory Pressure (MEP) as well as swallowing safety and voice function in head and neck cancer (HNC) survivors with dysphagia

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have survived head and neck cancer, completed treatment (surgery and or chemoradiotherapy) more than 3 months ago and are experiencing associated dysphagia (difficulty swallowing).

Study details:
All participants in this study will receive an Expiratory Muscle Strength Training device (EMST150) to use 5 days a week over 5 weeks at home, Participants will be required to attend a 1-hour in-person speech pathology appointment week 1 and 5 of the study, with weekly 15-minute telehealth consultations week 2, 3 and 4.

Participants will undergo some testing procedures pre and post the 5-week EMST therapy period to determine maximum expiratory pressure, swallowing safety, voice function and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136086 0
Miss Chelsea McGuinness
Address 136086 0
Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 136086 0
Australia
Phone 136086 0
+61 421 400 887
Fax 136086 0
Email 136086 0
[email protected]
Contact person for public queries
Name 136087 0
Chelsea McGuinness
Address 136087 0
Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 136087 0
Australia
Phone 136087 0
+61 421 400 887
Fax 136087 0
Email 136087 0
[email protected]
Contact person for scientific queries
Name 136088 0
Chelsea McGuinness
Address 136088 0
Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 136088 0
Australia
Phone 136088 0
+61 421 400 887
Fax 136088 0
Email 136088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Because of the heterogenous nature of the population, it is felt that if specific individual information were available, this would breach participant confidentiality and privacy. The purpose of the proposed study is the assess the effect of EMST in a head and neck cancer population, therefore the overall group results are felt to be more representative of the study's aims and objectives.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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