None listed
Conditions
Brief summary
The purpose of this study is to find out how blood flow to tumours changes during exercise in humans with breast cancer. Who is it for? You may be eligible for this study if you are a female aged 30-65 years who either does or does not have breast cancer. Study details All participants in this study will be asked to attend one clinic day where they will be asked to complete exercise on a bike for approximately 30 minutes. During this exercise, participants will undergo ultrasound assessment of blood flow in different parts of the body. It is hoped that this study will help determine if exercise can increase blood flow to tumours, which may in future indicate that exercise has the potential to enhance delivery of chemotherapy.
Interventions
This study aims to quantify the change in tumour blood flow with exercise. Specifically, contrast-enhanced ultrasound will be used to compare microvascular blood flow at rest vs immediately post-exercise and 30 min after exercise, in breast tumour, kidney, active and inactive muscle. Conduit artery blood flow in the femoral and brachial arteries will be recorded at the same time points.
Ten women with histologically confirmed breast cancer (breast cancer group) and ten weight- and age-matched
This study aims to quantify the change in tumour blood flow with exercise. Specifically, contrast-enhanced ultrasound will be used to compare microvascular blood flow at rest vs immediately post-exercise and 30 min after exercise, in breast tumour, kidney, active and inactive muscle. Conduit artery blood flow in the femoral and brachial arteries will be recorded at the same time points. Ten women with histologically confirmed breast cancer (breast cancer group) and ten weight- and age-matched women without breast cancer (control group) will be recruited. Following screening, consent and familiarisation, participants will have resting measures of blood flow taken, then they will complete 10 min low-moderate intensity cycling (warm-up, 55-65% age-predicted maximum heart rate), followed by 4 x 5-min bouts of moderate-high intensity cycling (70-80% age predicted maximum heart rate), each separated by a 3-min rest period. During cycling, participants will be asked to maintain 70 revolutions/minute, while researchers adjust bike resistance to attain the target heart rate. If heart rate drops too low or rises too high, resistance will be adjusted accordingly. Rating of perceived exertion (RPE) will be measured every 2.5 minutes during exercise to ensure participants are not exceeding an RPE range of 13- 16 (somewhat hard to hard). Importantly, if a participant reports an RPE of 19-20 (extremely hard) at any point then exercise will be stopped. Blood flow measures will be taken during the rest periods that follow each of the last 3 moderate-high intensity intervals (within 3 min) and then again 30 min after completion of the exercise protocol. The exercise protocol will be run by researchers who are accredited exercise physiologists with experience coordinating human clinical trials in exercise physiology and cardiovascular physiology. Blood flow measures will be taken by members of the researcher team who have extensive experience with the contrast-ultrasound technique (>500 measures), with guidance specific to the assessment of tumour blood flow provided by two clinical sonographers who have many years of experience in diagnostic breast ultrasound.
Sponsors
University of the Sunshine Coast
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria (breast cancer group): Have histologically confirmed HER2+ or triple negative breast cancer prior to surgical removal (neoadjuvant chemotherapy may have started, however there is a solid tumour visible with clinical ultrasound), aged 30-65 years, BMI < 30 kg/m2, can perform moderate to high intensity cycling exercise for 5-minute intervals, can speak and understand English, have given signed inform consent to participate in study. Inclusion Criteria (control group): Aged 30-65 years, BMI < 30 kg/m2, can perform moderate to high intensity cycling exercise for 5-minute intervals, can speak and understand English, have given signed inform consent to participate in study.
Exclusion criteria
Exclusion Criteria: History of myocardial infarction, stroke, dementia, diabetes, or respiratory disease, kidney donation or impairment, musculo-skeletal barriers to cycling exercise, uncontrolled hypertension (resting brachial blood pressure > 160/100 mmHg), any medical condition requiring immediate therapeutic intervention, poor ejection fraction, critical limb ischemia, current or previous smoker/vaper (within the last 12 months), pregnant or breastfeeding. For the control group, history of any cancers (except non-melanoma skin cancer) will be an exclusion criteria.
Outcome results
None listed