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Febrile Neutropenia clinical trials

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NCT ID: NCT02467868 Completed - Breast Neoplasms Clinical Trials

Efficacy and Safety Study With MYL-1401H and Neulasta

Start date: March 2015
Phase: Phase 3
Study type: Interventional

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.

NCT ID: NCT02428114 Completed - Clinical trials for Early Stage Breast Cancer

A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study)

React-G
Start date: May 2015
Phase: N/A
Study type: Observational

In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates for breast cancer patients. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increased susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a daily injection for 5, 7, or 10 days. Since there is genuine uncertainty amongst healthcare professionals as to which administration schedule of Neupogen is better, investigators are performing a randomized study in which patients are put into a group by chance to give participants one of three standards of Neupogen daily injection. Neupogen can cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of treatment this can cost $16,000 compared to a 5 day prescription which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high-cost. This study will use an "integrated consent model" that involves an "oral consent" rather than a written informed consenting process in order to increase the number of patients who may participate while performing a study at a lower cost. While determining the optimal treatment will improve patient comfort and acceptability, using the minimal safe duration of administration may also offer cost savings.

NCT ID: NCT02272673 Completed - Clinical trials for Acute Lymphoblastic Leukemia

The Effects of Honey on Febrile Neutropenia in Children With Acute Lymphoblastic Leukemia

Start date: March 2011
Phase: Phase 3
Study type: Observational

Febrile neutropenia (FN) is a common and serious side effect of chemotherapy. Current management of FN is expensive and may induce side effects. Honey is a natural substance produced by honeybees. It possesses antioxidant, antimicrobial and anticancer effects. In addition, honey is not expensive. The aim of this study was to evaluate the effects of 12-week honey consumption on children with acute lymphoblastic leukemia (ALL) particularly with regards of FN episodes. This randomized crossover clinical trial included 40 patients of both sexes, aged 2.5 to 10 years. They were randomized into two equal groups [intervention to control (I/C) and control to intervention (C/I)]. The dietary intervention was 12-week honey consumption in a dose of 2.5g//kg body weight per dose twice weekly.

NCT ID: NCT02213783 Completed - Clinical trials for Patients With Febrile Neutropenia

Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Start date: February 2011
Phase: Phase 4
Study type: Interventional

This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection. Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.

NCT ID: NCT02178475 Completed - Clinical trials for Chemotherapy-induced Febrile Neutropenia

Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy

Start date: July 18, 2014
Phase:
Study type: Observational

To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.

NCT ID: NCT02149329 Completed - Febrile Neutropenia Clinical Trials

Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO

SHORT
Start date: December 2014
Phase: Phase 4
Study type: Interventional

A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.

NCT ID: NCT02119715 Completed - Breast Cancer Clinical Trials

A Phase II Study Comparing Pegylated rhG-CSF(HHPG-19K) and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy

Start date: February 2011
Phase: Phase 2
Study type: Interventional

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

NCT ID: NCT02005783 Completed - Febrile Neutropenia Clinical Trials

Study of Danggui Buxue Decoction in Preventing Neutropenia

DIPE
Start date: October 2013
Phase: Phase 2
Study type: Interventional

To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy.

NCT ID: NCT01813721 Completed - Clinical trials for Chemotherapy-induced Febrile Neutropenia

Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.

Start date: December 2012
Phase: N/A
Study type: Observational

This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

NCT ID: NCT01799421 Completed - Clinical trials for Non-hematologic Cancer

Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy

NEURISK
Start date: October 2011
Phase: N/A
Study type: Observational

The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.