Chemotherapy-induced Neutropenia, Febrile Neutropenia, Gynecologic Cancer, Myelosuppression Adult
Conditions
Brief summary
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.
Interventions
DRUGLong-acting G-CSF
Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
DRUGShort-acting G-CSF
Short-acting G-CSF will be given as required 24 hours after the chemotherapy.
Sponsors
Lei Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed primary gynecologic cancer * Good performance status * Aged 18 years or older * Signed an approved informed consents * No immunosuppressive disease
Exclusion criteria
* Not meeting all of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia | One year | Incidence of febrile neutropenia in each course |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of grade 3/4 myelosuppression | One year | Incidences of grade 3/4 myelosuppression in each course |
| Times of visits to outpatient and emergency clinics | One year | Visits to outpatient and emergency clinics in each course |
| Doses of G-CSF | One year | Doses of G-CSF administrated in each course |
Countries
China
Contacts
Primary ContactLei Li
Outcome results
None listed