None listed
Conditions
Brief summary
The main purpose of this study is to assess if there is an association between cardiorespiratory fitness and acute aerobic exercise on tumour blood flow in patients with cancer that has spread to the liver. A secondary aim of the study is to determine the most effective exercise intensity for increasing tumour blood flow. Who is it for? You may be eligible for this study if you are aged over 18 and diagnosed with stage IV cancer with a liver metastases. Study details All participants in this study will be required to attend a single visit. Participants will perform an aerobic fitness test (YMCA). After a rest period, participants will ride on an exercise bike for 5 minutes, or take part in the sub-study which participants will complete 3 cycling tasks of varying difficulty. Each will last for 5 minutes and there will be a rest period in between each one. Physiological measurements will be taken before, during and after the intervention, including blood pressure, heart rate and oxygen saturation, as well as oxygen consumption and ultrasound measures. The study will extend the work of a current pilot study, investigating the safety and feasibility of intra-infusion aerobic exercise and help progress towards clinical application. The results will not provide a full picture into the mechanism or relationship of tumour blood flow and chemotherapy delivery but rather provide a platform for further research.
Interventions
All participants will complete a standardised a single YMCA fitness test. The test is performed on a cycle ergometer and involves three submaximal stages of increasing intensity. The test involves the participant pedaling at a cadence of 50 revolutions per minute (rpm) for at least 3 minutes at each of the three stages. If the heart rate at the second and third minutes varies by more than 5 bpm, the stage is extended for one minute or until steady state is achieved. Heart rate and VO2 of the las
All participants will complete a standardised a single YMCA fitness test. The test is performed on a cycle ergometer and involves three submaximal stages of increasing intensity. The test involves the participant pedaling at a cadence of 50 revolutions per minute (rpm) for at least 3 minutes at each of the three stages. If the heart rate at the second and third minutes varies by more than 5 bpm, the stage is extended for one minute or until steady state is achieved. Heart rate and VO2 of the last minute of each stage will be plotted. This is then extrapolated to the age-predicted maximum heart rate to predict maximal oxygen consumption (VO2max). The participant will rest for at least 10 minutes prior to commencing the next bout of exercise. Heart rate, blood pressure and oxygen saturation will be monitored throughout the rest period. The rest period will be extended beyond 10 minutes if required, until physiological measures return to baseline levels. Participants will complete a single bout of moderate intensity exercise. The participant will cycle at 46-56% VO2max (40-50% heart rate reserve (HRR)) for at least 5 minutes, until steady state heart rate has been reached. As per the YMCA test, the participant will rest for at least 10 minutes following exercise, until physiological markers return to baseline levels. A sub-group of 18 participants will complete three short (5 min) bouts of exercise in a single session. One will be at a low intensity (27-37% VO2max/20-30% HRR), one at a moderate intensity (46-56% VO2max/40-50% HRR) and one at a high intensity (64-74% VO2max/60-70% HRR). Individuals will be invited to participate in the sub-study if they possess aerobic fitness (VO2peak) of 18 ml/kg/min or above, as estimated during the aerobic fitness testing. The order of intensities performed will be randomised using a computer-generated random numbers list. Sealed envelopes containing the randomised exercise sequence will be opened in front of the participant on the day of testing. Following each exercise condition, the participant will rest for at least 10 minutes, until physiological markers return to baseline levels. All exercise interventions will be administered in a one-on-one mode, and will be supervised by an accredited Exercise Physiologist.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. Voluntarily signed the informed consent form b. Ability to speak and understand english c. Aged over 18 years d. Histologically confirmed stage IV cancer with a liver metastasis appropriate and easily accessible for Doppler ultrasound. e. ECOG 0-2 f. Treating oncologist approval g. Willingness and ability to comply with all study procedures
Exclusion criteria
a. Present with an acute systemic infection or fever b. Presence of any condition that is a contraindication to exercise c. Presence of orthopaedic problems, peripheral neuropathy or pain that would limit lower body exercise d. Currently taking beta-blocker medications
Outcome results
None listed