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

Phase 4

• Conditions: Chemotherapy-Induced Febrile Neutropenia; Granulocyte Colony-Stimulating Factor; Chemotherapy-induced Neutropenia; Pediatric Cancer
• Interventions: Drug: Granulocyte Colony-Stimulating Factor

• Registration Number: NCT03823950
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-31
• Study Start: 2019-02-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-13
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receive G-CSF 72 hours following chemotherapy	Granulocyte Colony-Stimulating Factor	Children will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit. Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy.

Primary Outcome Measures

Name	Time	Method
Incidence of hospital admissions for febrile neutropenia	From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year	Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500

Secondary Outcome Measures

Name	Time	Method
Days delayed in beginning the next course of chemotherapy	Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year	A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia
Duration of neutropenia	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	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

Trial Locations

Locations (1)

Univeristy of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States