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This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-acting G-CSF group | Experimental | Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF. |
|
| Short-acting G-CSF group | Experimental | Patients in long-acting G-CSF group only accept short-acting G-CSF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-acting G-CSF | Drug | Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia | Incidence of febrile neutropenia in each course | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of grade 3/4 myelosuppression | Incidences of grade 3/4 myelosuppression in each course | One year |
| Times of visits to outpatient and emergency clinics | Visits to outpatient and emergency clinics in each course |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li | Contact | +8613911988831 | lileigh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39696092 | Derived | Chen X, Wu M, Ma S, Tan X, Zhong S, Li L. Effects of long-acting versus short-acting granulocyte colony stimulating factor after radiotherapy in gynecologic malignancies: a prospective observational cohort study. BMC Cancer. 2024 Dec 18;24(1):1512. doi: 10.1186/s12885-024-13296-1. |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
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| Short-acting G-CSF | Drug | Short-acting G-CSF will be given as required 24 hours after the chemotherapy. |
|
| One year |
| Doses of G-CSF | Doses of G-CSF administrated in each course | One year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |