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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 epithelial ovarian cancer. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular treatment rather than long-acting G-CSF. The primary end is the incidence of FN in every course of chemotherapy. 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 |
|---|---|---|---|
| Study group | Experimental | Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression. |
|
| Control group | Active Comparator | Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| long-acting granulocyte colony stimulating factor | Drug | A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group |
|
| Measure | Description | Time Frame |
|---|---|---|
| febrile neutropenia | the incidence of febrile neutropenia happened during each course of chemotherapy | One year |
| Measure | Description | Time Frame |
|---|---|---|
| myelosuppression | the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy | One year |
| doses of granulocyte colony stimulating factor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | 13911988831 | 86 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31467066 | Derived | Li L, Ma S, Wu M, Tan X, Zhong S, Lang J. The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study. BMJ Support Palliat Care. 2019 Dec;9(4):373-380. doi: 10.1136/bmjspcare-2019-001862. Epub 2019 Aug 29. |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Short-term granulocyte colony stimulating factor | Drug | Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression |
|
total doses of all granulocyte colony stimulating factor
| One year |
| expenses of granulocyte colony stimulating factor | total expenses of all granulocyte colony stimulating factor | One year |
| visits to the hospital | visits to outpatient and emergency clinics | One years |
| adverse events | adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | One year |
| progression-free survival | progression-free survival after the primary treatment of ovarian cancer | Five years |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |