None listed
Conditions
Brief summary
Who is it for? This study will investigate whether breathing muscle strength training can be safely and successfully completed before major head and neck cancer surgery. You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with head and neck cancer and the planned treatment for your cancer is surgery followed by radiotherapy. This study will specifically enrol people who already have a respiratory condition and those who are expected to need a tracheostomy as part of their surgery. Study details All participants who choose to enrol in this study will be given a small handheld device to strengthen the muscles used for breathing and coughing before surgery. Participants will be shown how to use the device and will then be asked to complete 5 sets of exercises using the device each day before their surgery. At 4-6 weeks after surgery, participants will be asked to start using the device to complete exercises each day for the duration of their radiotherapy. This may be as few as 3 weeks or up to 6 weeks, depending upon the radiotherapy course. It is hoped this research will determine whether breathing muscle strength training can be safely delivered to people undergoing surgery for their head and neck cancer and whether this training is able to improve breathing, swallowing and tracheostomy-related outcomes after surgery.
Interventions
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 thei
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
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed