Clinical trial NCT02806557: Profiling Neutrophil Counts in Patients on Chemotherapy
Official title: Profiling Neutrophil Counts in Patients With Cancer During Cycle One of Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms
Neutropenia
Febrile Neutropenia
Keywords: Neoplasms
Neutropenia
drug therapy
Hematologic tests
Point-of-care Systems
Febrile neutropenia
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2016-06-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with solid tumours receiving systemic anti-cancer therapy.

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.
timeFrame: 18 months
Secondary outcomes:
measure: The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications.
timeFrame: 18 months
measure: The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications.
timeFrame: 18 months
Other outcomes:
measure: The proportion of patients who decline to enter the study or withdraw from it due to finger-prick capillary sampling.
timeFrame: 18 months
measure: The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications, when primary prophylactic granulocyte colony stimulating factor is administered.
timeFrame: 18 months
measure: The proportion of patients in whom the neutrophil count does not reach grade 1 neutropenia or worse.
timeFrame: 18 months
measure: The proportion of patients in whom the neutrophil count surpasses the threshold for re-treatment in advance of their planned cycle 2 date.
timeFrame: 18 months
measure: The proportion of patients in whom the neutrophil count is below the threshold for retreatment when cycle 2 is due to be delivered.
timeFrame: 18 months
measure: Estimate cost implications of using home neutrophil count monitoring during chemotherapy using Markov modelling.
timeFrame: 18 months
Locations:
Study officials:
affiliation: University of Leeds
name: Geoff Hall, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.