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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
126
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
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, Thailand
Rajavithi Hospital
Bangkok, Bangkok, Thailand
Internal Medicine Unit, Pranongklao Hospital
Nontaburi, Nontaburi, Thailand
Incidence of febrile neutropenia
Incidence of febrile neutropenia in each course
Time frame: One year
Incidence of leukopenia and neutropenia
Incidence of leukopenia and neutropenia in each course
Time frame: One year
Incidence of grade 3 or 4 of myelosuppression
Incidence of 3 or 4 myelosuppression in each course
Time frame: One year
Time of visits to outpatient (OPD) and emergency clinics (ER)
Incidence of visit to OPD or ER in each course
Time frame: One year
Quality of life (QoL) after chemotherapy
Quality of life score daily in each course
Time frame: One year
Supat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D.
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