Clinical trial · Observational

Profiling Neutrophil Counts in Patients on Chemotherapy

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

NCT02806557CI-TRIAL-00023320unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Febrile Neutropenia	—	UNRESOLVED	—
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90
Neutropenia	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Home finger-prick capillary blood count monitoring	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

label
High risk group
description
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).
interventionNames
1. Device: Home finger-prick capillary blood count monitoring
label
Frequently given regimens
description
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).
interventionNames
1. Device: Home finger-prick capillary blood count monitoring
label
Prophylactic GCSF
description
Patients on primary prophylactic granulocyte colony stimulating factor (GCSF). The intervention is home finger-prick capillary blood count monitoring (up to daily).

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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).

References

Publications (4)

BACKGROUNDBodey 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. PMID 5216294
BACKGROUNDRao 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. PMID 18187044
BACKGROUNDRao, 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.
BACKGROUNDBergh 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. PMID 11052580