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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Ramsey
Cutress
+44 (0)23 8120 4946
R.I.Cutress@soton.ac.uk
Dr
Kesta
Durkin
+44 (0)2381204578
K.L.Durkin@soton.ac.uk
Breast cancer
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Some patients with early breast cancer are treated with chemotherapy before or after surgery to remove the tumour from the breast. This chemotherapy is given with the aim of eradicating any cancer cell that have already escaped into the general circulation and therefore reduce the risk of the cancer returning in the future. Chemotherapy treatment in this setting is most effective if patients receive the optimum dose of chemotherapy on time without delays in their treatment or reductions in their chemotherapy doses. Chemotherapy doses are currently calculated from a patient’s height and weight. However, these calculations were designed for normal weight patients and this has resulted in uncertainty as to whether obese patients are being dose with chemotherapy correctly. We know that approximately 26% of British women are considered to be obese and that obese breast cancer patients have a higher risk of disease recurrence than healthy-weight patients. A review by the American Society of Oncologists suggested that oncologists may underdose obese patients and our own data suggests that some obese patients may be more at risk of experiencing severe side effects from chemotherapy than healthy weight patients, resulting in treatment delays.
Obesity is defined by body mass index which is also a calculation from height and weight and does not take into account the fact that people of the same size can have different amounts of blood, muscle and fatty tissue which can all affect the behaviour of drugs. Detailed assessments of lean and fat patterns, (body composition), can now be obtained within a few minutes using a technique called bioelectrical impedance analysis (BIA). Our pilot study, CANDO-2, has confirmed that data on the body composition of early breast cancer patients attending routine chemotherapy out-patients can be collected quickly and easily by asking patients to stand on a segmental BIA analyser for a few minutes after they have undergone their usual weight measurement, and that these measurements may help predict when patients might need to unexpectedly return to hospital during chemotherapy for side effects or problems. In this study we will be collecting body composition data from over 300 women receiving routine chemotherapy before or after breast surgery across several hospital sites in the UK. We will collect information for each patient about the chemotherapy drugs and doses they receive and the side effects they experience to investigate how different patterns of body composition affect response to chemotherapy.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2022 Protocol article in http://dx.doi.org/10.1136/bmjopen-2021-054412 (added 20/09/2022)
You can take part if:
Current inclusion criteria as of 26/04/2023: You may not be able to take part if: Current participant exclusion criteria as of 11/02/2022:1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) within the past 10 years2. Any other medical conditions preventing physical participation in the study procedures3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies5. Pregnancy6. Pacemakers
1. Early invasive breast carcinoma
2. Stage I-III disease
3. Tumour grade, ER and HER 2 status available
4. Clinical or pathological tumour size and lymph node status available
5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multidisciplinary meeting
6. No prior systemic anti-cancer treatment within the past 10 years (hormonal therapy started
since current breast cancer diagnosis (e.g. neoadjuvant or bridging endocrine therapy allowed)
7. No evidence of distant metastatic disease
8. Patient agrees to receive neo/adjuvant chemotherapy
9. Planned to receive greater than 4 x 21-day cycles of anthracycline or taxane-based
combination chemotherapy. 21-day combination regimens including weekly treatments are
allowed e.g. 1. carboplatin D1/paclitaxel D1, D8, D15 2. EC-weekly paclitaxel. Patients planned to
receive the anthracycline component of the chemotherapy regimen at 2-weekly intervals
(accelerated regimens) are additionally eligible for inclusion
10. Aged ≥18 years and <80 years
11. Female
Previous exclusion criteria as of 24/08/2021: :1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) within the past 10 years2. Any other medical conditions preventing physical participation in the study procedures3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies5. Pregnancy
Previous exclusion criteria as of 27/07/2021:1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer)2. Any other medical conditions preventing physical participation in the study procedures3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies5. Pregnancy
Previous exclusion criteria:1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer)2. Any other medical conditions preventing physical participation in the study procedures3. Patients receiving single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies5. Pregnancy
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Ramsey
Cutress
+44 (0)23 8120 4946
R.I.Cutress@soton.ac.uk
Dr
Kesta
Durkin
+44 (0)2381204578
K.L.Durkin@soton.ac.uk
The study is sponsored by University Hospital Southampton NHS Foundation Trust and funded by World Cancer Research Fund International.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
