The purpose of this trial is to observe the changes in white cell counts in patients with cancer during chemotherapy and to determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications.
Neutropenia is a low count of the type of white blood cells that fight bacterial infection. It is a common toxicity of chemotherapy given for cancer. When complicated by infection, it can necessitate urgent admission to hospital, and can be life-threatening. Recovery of neutrophils is necessary prior to delivery of further chemotherapy. The information available on the changes of neutrophils during chemotherapy is limited by the frequency of blood tests which have historically required a venous blood sample and hence are burdensome to the patient. There are point-of-care medical devices which measure the white blood cell count from a capillary finger-prick sample, and can be used in the patient's home. The investigators aim to use such a device in this trial to; (i) observe the changes in white cell counts following chemotherapy delivery, (ii) determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications. This trial forms part of a larger project in which the investigators are exploring the role of home blood count monitoring in the management of severe neutropenia and its complications, and exploring the potential for home blood count monitoring to be used to optimise the dose intensity and density of chemotherapy. This is a non-randomised trial in adults with solid tumours, recruiting from Leeds Teaching Hospitals NHS Trust only. Consenting participants are required to have regular finger-prick blood tests up to a maximum frequency of daily for the duration of the first cycle of chemotherapy, most commonly 3 weeks. A nurse will visit the participant at home and use the Hemocue® WBC DIFF to perform the test. This trial is funded by a Technology Strategy Board (Innovate UK) Small Business Research Initiative grant.
Study Type
OBSERVATIONAL
Enrollment
200
A nurse will visit the participant's home according to the test schedule (up to a maximum frequency of 21 visits in a 21-day cycle) and perform the finger-prick capillary blood test and measure the neutrophil count using the Hemocue® WBC DIFF device.
The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.
Time frame: 18 months
The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications.
Time frame: 18 months
The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications.
Critical time points for measuring neutrophil counts will be determined dependent upon patterns of neutrophil changes observed and the gradient of neutrophil changes will be categorized according to limits determined by logistic regression modelling and hazard ratio calculations.
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.