Profiling Neutrophil Counts in Patients on Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Profiling Neutrophil Counts in Patients With Cancer During Cycle One of Chemotherapy

Conditions
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Neoplasms, Neutropenia, Febrile Neutropenia

Intervention / Treatment
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* Device: Home finger-prick capillary blood count monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid tumour diagnosis. Adults ≥ 18 years. Receiving either single agent or combination cytotoxic chemotherapy alone or in combination with other targeted or immunotherapies. Participants can be receiving primary prophylactic antibiotics or GCSF. Live within boundaries of Local Care Direct service provision. Exclusion Criteria: Inability to give informed consent. Concurrent haematological malignancy. Known bleeding disorder. Known sickle cell disease or β-thalassaemia major. Known poorly controlled anti-coagulation (INR >3.5 within 6 months for those on warfarin).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk group<br>Defined as risk of severe neutropenia >20% or risk of neutropenic infective complications >10%, with severe neutropenia defined as absolute neutrophil count <1.0 x10^9/L. The intervention is home finger-prick capillary blood count monitoring (up to daily). | Device: Home finger-prick capillary blood count monitoring<br>* 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.<br>* Other names: Hemocue® WBC DIFF;|
| Frequently given regimens<br>Defined as high number of cases of neutropenia, but risk of severe neutropenia <5%. The intervention is home finger-prick capillary blood count monitoring (up to daily). | Device: Home finger-prick capillary blood count monitoring<br>* 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.<br>* Other names: Hemocue® WBC DIFF;|
| Prophylactic GCSF<br>Patients on primary prophylactic granulocyte colony stimulating factor (GCSF). The intervention is home finger-prick capillary blood count monitoring (up to daily). | Device: Home finger-prick capillary blood count monitoring<br>* 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.<br>* Other names: Hemocue® WBC DIFF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications. |  | 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Neutropenia, drug therapy, Hematologic tests, Point-of-care Systems, Febrile neutropenia