Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001148369p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
20/08/2026
Date registered
Help: Date registered
16/09/2026
Date last updated
Help: Date last updated
16/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
16/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of breathing muscle strength training before surgery in people undergoing major head and neck cancer surgery
Scientific title
Feasibility and acceptability of preoperative expiratory muscle strength training (EMST) in patients undergoing major head and neck cancer surgery with planned tracheostomy or pre-existing respiratory disease
Additional trial identifiers [1] 318217 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Head and Neck Cancer 343294 0
Condition category
Condition code
Cancer 339409 339409 0 0
Head and neck
Surgery 339410 339410 0 0
Other surgery
Respiratory 339549 339549 0 0
Chronic obstructive pulmonary disease
Respiratory 339550 339550 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is self-administering an EMST device that is calibrated to 75% of a participant's baseline maximum expiratory pressure (MEP). An EMST device is a small, handheld device that you breathe into.

This intervention is self-administered under speech pathologist guidance.

The standard regimen is 5 repetitions × 5 sets daily (25 reps/day) with weekly upward adjustment as tolerated, and under guidance of the speech pathologist. This will be for less than 2 weeks in the lead up to their surgery.

EMST is resumed approximately 4–6 weeks post-surgery, contingent on clearance from the treating surgical team. The intervention continues through the adjuvant radiation therapy (RT) course, typically 6 weeks. The same standard regimen continues, including the upward adjustment under guidance of the speech pathologist.

As it is self-administered, it can be done at the participant's home.

Adherence to this regimen is self reported on the day prior to surgery. Adherence during prehabilitation phases is self-reported and rated using the following 4-point ordinal scale:
• More than recommended
• As recommended
• Less than recommended
• No exercise
Intervention code [1] 335129 0
Prevention
Intervention code [2] 335130 0
Rehabilitation
Description of the comparator or control
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346617 0
Feasibility- Recruitment rate
Timepoint [1] 346617 0
Each month of the study duration until recruitment is complete
Primary outcome [2] 346618 0
Feasibility- Dropout rate
Timepoint [2] 346618 0
Recorded on the day prior to participant's surgery
Primary outcome [3] 346619 0
Feasibility- Adherence
Timepoint [3] 346619 0
The day prior to surgery, last day of adjuvant RT, 3 months post-radiation oncology follow-up
Secondary outcome [1] 466771 0
Feasibility- Adverse event rate
Timepoint [1] 466771 0
Monitored throughout the study, every 3 months for a maximum of 1 year post-commencement
Secondary outcome [2] 466772 0
Maximum expiratory pressure (MEP)
Timepoint [2] 466772 0
Baseline (preadmission), Day prior to surgery, Hospital discharge, Start of adjuvant RT, Last day of adjuvant RT, 3-month post-RT RadOnc follow-up
Secondary outcome [3] 466773 0
Peak Expiratory Flow
Timepoint [3] 466773 0
Baseline (preadmission), Day prior to surgery, Hospital discharge, Start of adjuvant RT, Last day of adjuvant RT, 3-month post-RT RadOnc follow-up
Secondary outcome [4] 466774 0
Functional Oral Intake
Timepoint [4] 466774 0
Baseline (preadmission), Day prior to surgery, Hospital discharge, Start of adjuvant RT, Last day of adjuvant RT, 3-month post-RT RadOnc follow-up
Secondary outcome [5] 467361 0
Tracheostomy Decannulation Status
Timepoint [5] 467361 0
Status at discharge

Eligibility
Key inclusion criteria
Adults 18 years and above with confirmed Head and Neck cancer requiring surgical resection, with planned tracheostomy OR clinician-confirmed/spirometry-verified significant respiratory disease (e.g., COPD), and English adequate for consent or interpreter available.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Recent abdominal/thoracic surgery (<6 weeks), active hernia, pregnancy, history of spontaneous pneumothorax, active haemoptysis, untreated severe hypertension or recent cardiac event, cognitive impairment precluding home-based program adherence.

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/10/2026
Actual
Date of last participant enrolment
Anticipated
1/09/2030
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322779 0
Hospital
Name [1] 322779 0
Chris O'Brien Lifehouse
Country [1] 322779 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 325722 0
None
Name [1] 325722 0
Address [1] 325722 0
Country [1] 325722 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321220 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 321220 0
Ethics committee country [1] 321220 0
Australia
Date submitted for ethics approval [1] 321220 0
29/09/2026
Approval date [1] 321220 0
Ethics approval number [1] 321220 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153050 0
Dr Emma Charters
Address 153050 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 153050 0
Australia
Phone 153050 0
+61413660776
Fax 153050 0
Email 153050 0
[email protected]
Contact person for public queries
Name 153051 0
Emma Charters
Address 153051 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 153051 0
Australia
Phone 153051 0
+61413660776
Fax 153051 0
Email 153051 0
[email protected]
Contact person for scientific queries
Name 153052 0
Emma Charters
Address 153052 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 153052 0
Australia
Phone 153052 0
+61413660776
Fax 153052 0
Email 153052 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.