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Medicine

Research project: CANDO-3: Body composition and chemotherapy toxicity in women with early breast cancer

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The CANDO-3 study investigates how different patterns of body composition affect the response to chemotherapy treatment in women with early breast cancer.

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.

Calculations using height and weight do 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). In this study we will be collecting body composition data from over 300 women receiving routine chemotherapy before or after breast surgery across seven 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.

Study purpose:

The aims of the CANDO-3 study are to determine:

  • If higher fat mass index (fat mass adjusted for differences in height) is associated with increased grade 3 or higher chemotherapy toxicity in women receiving chemotherapy for early breast cancer;
  • The prognostic potential of bioelectrical impedance analysis derived body composition measures including fat free mass index (fat free mass adjusted for differences in height) in predicting grade 3 or higher chemotherapy toxicity;
  • To determine whether early breast cancer patients with different body composition patterns are planned and delivered the same chemotherapy dose intensity;
  •  To determine the relationship between bioelectrical impedance-measured physical properties e.g. phase angle and reactance and grade 3 or higher chemotherapy toxicity;
  • To determine in exploratory analyses the association of body composition measures across all grades of chemotherapy toxicities.

Study design:

The CANDO-3 study is an observational cohort study funded by the World Cancer Research Fund that aims to recruit 300 women diagnosed with early breast cancer who have been recommended to have chemotherapy, either before or after surgery. Patients will be recruited from across 7 UK hospital sites.  They will be followed throughout their cancer treatment and again 3 months after treatment has finished.  They will be involved in the study from 36-40 weeks. Patients’ breast cancer treatment will proceed exactly as already planned and will not be changed in any way by participating in the study.

Inclusion and exclusion criteria

Women will be eligible if: They have early invasive breast cancer; stage I-III disease; agree to have 4-6, 21-day cycles of chemotherapy.  They will be excluded if they: have had any previous invasive malignant cancers; have metastatic disease; are prescribed weekly chemotherapy; are pregnant.  Eligible patients will be asked to provide written, informed consent and will undergo some nonintrusive body measurements on the same days as their routine breast cancer treatment.

Ethical approval:

The CANDO-3 study obtained ethical approval from the Hampshire B research ethics committee (19/SC/0596) was granted on 30th January 2020.

Recruitment:

The CANDO-3 study is currently open to recruitment at University Hospital Southampton. It will also open at 6 other centres (Royal Devon and Exeter NHS Foundation Trust, Salisbury NHS Foundation Trust, Hampshire hospitals NHS Foundation Trust, The Christie NHS Foundation Trust, Oxford University Hospitals NHS Foundation Trust and Portsmouth Hospitals NHS Trust). If you are being treated at any of these centres and are recommended chemotherapy you may be able to take part.

More information:

If you have been diagnosed with stage I-III, early invasive breast cancer at one of these centres, agreed to receive chemotherapy and are interested in participating in the CANDO-3 study please contact the breast research team at your hospital.

Funding:

World Cancer Research Fund.

Associated research themes

Southampton Centre for Biomedical Research:

University of Southampton Academic Unit of Cancer Sciences

Association of Breast Surgery

ISRCTN

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