Profiling Neutrophil Counts in Patients on Chemotherapy

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02806557
• Other study ID #: MO16/191
• Status: Not yet recruiting
• Phase: N/A
• First received: May 26, 2016
• Last updated: July 29, 2016
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: July 2016
• Source: University of Leeds
• Contact: Geoff Hall, FRCP, PhD
• Phone: +44 113 2068970
• Email: g.hall[@]leeds.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-thalassaemia major.

• Known poorly controlled anti-coagulation (INR >3.5 within 6 months for those on warfarin).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neoplasms
• Neutropenia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Philips Healthcare

References & Publications (4)

Bergh J, Wiklund T, Erikstein B, Lidbrink E, Lindman H, Malmström P, Kellokumpu-Lehtinen P, Bengtsson NO, Söderlund 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. Erratum in: Lancet 2000 Dec 23-30;356(9248):2196. — View 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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of patients who decline to enter the study or withdraw from it due to finger-prick capillary sampling.		18 months	No
Other	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.	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	No
Other	The proportion of patients in whom the neutrophil count does not reach grade 1 neutropenia or worse.		18 months	No
Other	The proportion of patients in whom the neutrophil count surpasses the threshold for re-treatment in advance of their planned cycle 2 date.		18 months	No
Other	The proportion of patients in whom the neutrophil count is below the threshold for retreatment when cycle 2 is due to be delivered.		18 months	No
Other	Estimate cost implications of using home neutrophil count monitoring during chemotherapy using Markov modelling.	The trial data will inform the decision ratios in the Markov model. Aggregated costs associated with each pathway have been calculated using Health Resource grouper software for finished consultant episodes from an audit of patients receiving chemotherapy over a 10 year period at a large Cancer Centre in the United Kingdom. The real numbers and potential numbers in each pathway will be compared to estimate the cost implications.	18 months	No
Primary	The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.		18 months	No
Secondary	The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications.		18 months	No
Secondary	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	No