Profiling Neutrophil Counts in Patients on Chemotherapy
NCT ID: NCT02806557
Last Updated: 2016-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2016-09-30
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High risk group
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).
Home finger-prick capillary blood count monitoring
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.
Frequently given regimens
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).
Home finger-prick capillary blood count monitoring
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.
Prophylactic GCSF
Patients on primary prophylactic granulocyte colony stimulating factor (GCSF).
The intervention is home finger-prick capillary blood count monitoring (up to daily).
Home finger-prick capillary blood count monitoring
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.
Interventions
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Home finger-prick capillary blood count monitoring
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
University of Leeds
OTHER
Responsible Party
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Dr Geoff Hall
Principal Investigator
Principal Investigators
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Geoff Hall, FRCP, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Central Contacts
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References
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Bodey GP, Buckley M, Sathe YS, Freireich EJ. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med. 1966 Feb;64(2):328-40. doi: 10.7326/0003-4819-64-2-328. No abstract available.
Rao LV, Ekberg BA, Connor D, Jakubiak F, Vallaro GM, Snyder M. Evaluation of a new point of care automated complete blood count (CBC) analyzer in various clinical settings. Clin Chim Acta. 2008 Mar;389(1-2):120-5. doi: 10.1016/j.cca.2007.12.006. Epub 2007 Dec 14.
Rao, L.V., Moiles, D., Vallero, G.M. and Snyder, M. Finger-Stick Complete Blood Counts: comparison between venous and capillary blood. Point of Care The Journal of Near-Patient Testing & Technology. 2011, 10(3), pp.120-122.
Bergh J, Wiklund T, Erikstein B, Lidbrink E, Lindman H, Malmstrom P, Kellokumpu-Lehtinen P, Bengtsson NO, Soderlund G, Anker G, Wist E, Ottosson S, Salminen E, Ljungman P, Holte H, Nilsson J, Blomqvist C, Wilking N. Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial. Scandinavian Breast Group 9401 study. Lancet. 2000 Oct 21;356(9239):1384-91. doi: 10.1016/s0140-6736(00)02841-5.
Other Identifiers
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MO16/191
Identifier Type: -
Identifier Source: org_study_id
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