None listed
Conditions
Brief summary
This study will investigate the impact of chemotherapy on vascular and metabolic parameters that may predispose to cardio-metabolic illness after cancer. Who is it for? You may be eligible to join this study if you are a female aged at least 18 years who has been diagnosed with early stage breast cancer, for which you are due to commence chemotherapy. Healthy age and gender matched control patients will also be recruited to provide a benchmark for comparison. Study details All participants in this study will undergo interviews, questionniares, cardiovascular investigations, and metabolic investigations. This will involve insertion of intravenous cannulas (i.e. into the vein), so that blood samples can be taken. Breast cancer patients will be assessed at 3 timepoints over 9 months, i.e. at baseline (just prior to first chemotherapy) 3 months and then 9 months later. Healthy volunteers will be assessed on a single occasion only. The following assessments will take place at each visit; Study procedures: Participant presents after overnight fast. The visit will take about 5-6 hours. General Assessment: Measuring weight, height, waist and hip circumference, heart rate, blood pressure and temperature will be recorded. Assessment of cardiovascular risk: Measurement of arterial stiffness: assessed by measuring the pressure wave the heart produces in arteries with a small blunt probe. Assessment is not painful and usually takes about 30 minutes to complete. Measurement of autonomic nervous system activity: measured non-invasively: small changes in heart rate and blood pressure will be measured. Urine test: the specimen will then be sent to the lab to be tested for the amount of some chemicals which help measure the activity of the sympathetic nervous system. Measurement of endothelial function: measured by placing a probe on one finger of each hand to record pulsation of the arteries in the finger. By measuring the change in blood vessels after a blood pressure cuff on the arm is inflated and then deflated. Blood tests: A needle will be inserted into a vein in one arm, with a small plastic tube (drip) left in from which we will take blood samples. A baseline blood sample will be taken from you. You will then be asked to eat a meal over 15 minutes; then a series of blood samples will be collected from intravenous catheter over the two hours following the meal. In all, about 75mL of blood (less than one sixth of a blood donation) will be collected as part of this test. The results from these blood tests will tell us how much insulin the body makes in response to the meal. Additional blood samples: When we take the first blood sample before the meal we will also take an additional sample. This could be used to measure the cholesterol and other markers of cardiovascular risk that show up in your blood. Assessment of energy intake and expenditure: Estimating Energy intake: through an interview by on the doctors or nurses involved in the study, and asking to tell us what you have eaten over the last 24 hours. (10 to 15 minutes.) Physical activity: We will ask you to complete a questionnaire to tell us of your physical activity levels over the last 7 days. (10 to 15 minutes) Indirect calorimetry: measures the rate of energy expenditure before and after the meal. A clear plastic hood will be placed over the head for 20 minutes. You can breathe normally while under the hood and it does not restrict the amount of oxygen you inhale. The hood is connected to a machine that measures the energy expenditure Measurement of brown fat activity: by taking a picture with a special infrared camera before and after the meal that measures the temperature in the supraclavicular fossa (lower neck) very accurately. Measurement of body composition using a DEXA machine (the same machine that is used to measure bone density). You will be asked to lie on a bed while a scanner takes a picture of you. The scan is painless and takes about 10 minutes.
Interventions
Sponsors
Eligibility
Inclusion criteria
1. Female with histologically proven invasive breast cancer 2. American Joint Committee on Cancer (AJCC) Tumour Node Metastasis (TNM) Stage I - III disease 3. Age equal to or greater than 18 years 4. To commence adjuvant chemotherapy for breast cancer 5. ECOG Performance Status 0-2 Inclusion criteria for age and gender matched controls 1. Female 2. Age within 5 years of matched patient’s age 3. No current or previous diagnosis of cancer
Exclusion criteria
1. Current use of insulin or oral hypoglycaemic agents 2. Current use of beta blockers 3. Current use of antiplatelets/anticoagulants including aspirin, clopidogrel, warfarin, heparin 4. Presence of atrial fibrillation 5. Diagnosis of Raynaud’s syndrome 6. History of claustrophobia 7. Medical or psychiatric condition that compromises the subject’s ability to give informed consent 8. Difficult venous access 9. Large chest wall seroma