Overview
In this observational cohort study we will be collecting bioelectrical impedance body composition data from women receiving routine chemotherapy before or after breast surgery. 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.
Objectives
- To determine if Fat Mass index at baseline by bioelectrical impedance, as measured by mean Fat Mass corrected for differences in height, according to patients with/without grade ≥3 toxicity.
- To determine the prognostic potential of bioelectrical impedance analysis-derived body composition measures including Fat Free Mass index in predicting grade 3 or higher chemotherapy toxicity.
Inclusion criteria
We plan to recruit those with early invasive breast cancer planned to receive 4-6, 21 day cycles of anthracycline or taxane based combination neo-adjuvant or adjuvant systemic chemotherapy
Sample size
Three hundred participants (40-45 participants/site).
Sites
University Hospital Southampton NHS Foundation Trust; Royal Devon and Exeter NHS Foundation Trust; Salisbury NHS Foundation Trust; Hampshire Hospitals NHS Foundation Trust (Winchester); The Christie NHS Foundation Trust (Manchester); Oxford University Hospitals NHS Foundation Trust; and Portsmouth Hospitals NHS Trust.
Timeline
An 18 month recruitment period with assessments prior to every chemotherapy cycle, 3 weeks after and then again at 3 months after their final chemotherapy cycle. It is anticipated that all 7 hospital sites will be open to recruitment by the end of 2020.
Contact information
Further information can be obtained by contacting cando3@soton.ac.uk