Starting Granulocyte Colony-Stimulating Factor at 1 Day vs 3 Days Following Chemotherapy in Pediatric Cancer Patients

University of Mississippi Medical Center150 enrolled

Overview

Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. The purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. The current study aims to fill these research gaps and address the general question: Can G-CSF safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Granulocyte Colony-Stimulating Factor Chemotherapy-induced Neutropenia Chemotherapy-Induced Febrile Neutropenia Pediatric Cancer

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria: 1. are between the ages of birth and 21 years old 2. is diagnosed with an oncologic disease 3. is being treated at UMMC Children's Cancer Clinic 4. will receive G-CSF as part of their standard or experimental oncology treatment protocol between January 1, 2019 and December 31, 2019. Oncology treatment protocols are typically derived from the Children's Oncology Group standard of care or patients can be enrolled on a Children's Oncology Group treatment study. 5. is within first four courses of chemotherapy treatment Exclusion Criteria: * Patients will be excluded from the current study if: 1. G-CSF was added to their oncology treatment protocol due to previous complications but for whom G-CSF was not part of their original treatment protocol. 2. are being treated for relapsed disease 3. has clinical evidence of bone marrow involvement

Outcomes

Primary Outcomes

Incidence of hospital admissions for febrile neutropenia

Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500

Time frame: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year

Secondary Outcomes

Duration of neutropenia

The number of days between the first documented ANC less than or equal to 500 and the first documented ANC greater than 500 following nadir

Time frame: From date of first recorded ANC following chemotherapy until date of first ANC that is greater than 500 following nadir, assessed up to 1 year

Days delayed in beginning the next course of chemotherapy

A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia

Time frame: Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year