Febrile Neutropenia (FN), Granulocyte Colony Stimulating Factor, Myelosuppression Adult, Non-Hodgkin's Lymphoma (NHL)
Conditions
Keywords
Non-Hodgkin's lymphoma, Febrile neutropenia, Granulocyte Colony Stimulating Factor, Myelosuppression
Brief summary
The goal of this clinical trial is to Primary Objectives: 1. To compare the incidence of febrile neutropenia in patients with non-Hodgkin's lymphoma who received early or late granulocyte colony-stimulating factor (G-CSF) during standard chemotherapy in a multicenter study 2. To determine the incidence of leukopenia and neutropenia in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy in a multicenter study Secondary Objectives: 1. To determine changes in white blood cell, hemoglobin, and platelet levels in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy. 2. To determine the quality of life of patients with non-Hodgkin's lymphoma who undergoing standard chemotherapy and with neutropenia Researchers will compare the outcome between patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours). All patients will be followed up to monitor for febrile neutropenia events, other hematological parameters and quality of life.
Detailed description
This study aims to analyze the impact of the timing of granulocyte colony-stimulating factor (G-CSF) administration on the prevention of febrile neutropenia (FN) in non-Hodgkin's lymphoma patients undergoing standard chemotherapy. G-CSF is a growth factor that stimulates the production of white blood cell in order to fighting infection. When non-Hodgkin's lymphoma patients receive chemotherapy for eradicating cancer cells. They also have collateral damage those white blood cells and other hematopoietic cell lines. All patients received standard chemotherapy regimens once every four weeks. The study will compare the efficacy of early G-CSF administration, or late administration, after each course of chemotherapy. The primary endpoint is the incidence of FN in each chemotherapy course. At the end of each chemotherapy course, patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours). All patients will be followed up to monitor for FN events. Secondary endpoints include the incidence of myelosuppression and quality of life, assessed during outpatient and emergency department visits.
Interventions
Early receiving G-CSF group will be given within 72 hours post chemotherapy
Late receiving G-CSF group will be given after 72 hours post chemotherapy
Sponsors
Study design
Intervention model description
Group A: Early receiving G-CSF Group B: Late receiving G-CSF
Eligibility
Inclusion criteria
* Aged 18 years or old * Confirmed lymphoma undergoing standard chemotherapy * Signed an approval informed consent * Has a good understanding of Thai * Available for follow-up after chemotherapy
Exclusion criteria
* Pregnancy or lactation * Serious concomitant diseases and discontinuous treatment such as cardiovascular, liver, or kidney diseases * Contraindication to chemotherapy or G-CSF administration * Antibiotic use within 1 week prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia | One year | Incidence of febrile neutropenia in each course |
| Incidence of leukopenia and neutropenia | One year | Incidence of leukopenia and neutropenia in each course |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 3 or 4 of myelosuppression | One year | Incidence of 3 or 4 myelosuppression in each course |
| Time of visits to outpatient (OPD) and emergency clinics (ER) | One year | Incidence of visit to OPD or ER in each course |
| Quality of life (QoL) after chemotherapy | One year | Quality of life score daily in each course |
Countries
Thailand