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

Pediatric Cancer Clinical Trial

Official title:

A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823950
• Other study ID #: 2018-0082
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: June 2022

Study information

• Verified date: March 2020
• Source: University of Mississippi Medical Center
• Contact: Anderson B Collier, MD
• Phone: 601-984-5221
• Email: acollier[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Granulocyte Colony-Stimulating Factor
Begin G-CSF 72 hours following chemotherapy

Locations

Country	Name	City	State
United States	Univeristy of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Needle distress	Distress Rating Tool: The DRS version for 2-, 3-, and 4-year-olds has three faces with different facial expressions for children to point to the one that best matches how they feel. The version for 5- and 6-year-olds has a visual analog scale presented as a thermometer with a happy face drawn next to the 0 and a sad face drawn next to the 10. The DRT version for youth 7 to 18 years defines distress as 'worry, anxiety, sadness, or fear,' on a scale from 0 (no distress) to 5 (moderate distress) to 10 (high distress). The adult DRS will be used for youth 19 to 21 years. Caregivers will rate their perception of their child's distress	2 days
Other	Physical Side Effects	Memorial Symptom Assessment Scale: Physical and psychological symptoms; 8 items on 3-4 point scale (7-12 yrs) during past 2 days; 22 items on 4-5 point scale (10-14 yrs) during past week	1 week
Primary	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	From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year
Secondary	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	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
Secondary	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	Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year