Profiling Neutrophil Counts in Patients With Cancer During Cycle One of Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.
时间窗: 18 months
次要结局
- 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.(18 months)
研究者
Dr Geoff Hall
Principal Investigator
University of Leeds