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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive G-CSF 72 hours following chemotherapy | Experimental | 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. |
|
| Historical Controls | No Intervention | Four matched historical controls who received G-CSF at 24 hours following chemotherapy for each patient enrolled will be selected as each enrolled patient completes G-CSF therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granulocyte Colony-Stimulating Factor | Drug | Begin G-CSF 72 hours following chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria:
Exclusion Criteria:
Patients will be excluded from the current study if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anderson B Collier, MD | Contact | 601-984-5221 | acollier@umc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anderson B Collier, MD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
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| 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 |
| 2 days |
| 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 |
| ID | Term |
|---|---|
| D064146 | Chemotherapy-Induced Febrile Neutropenia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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