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Test, in a randomized phase II trial, the safety and efficacy of lactoferrin prophylaxis in preventing the occurrence of febrile neutropenia and sepsis, with particular regard to forms due to multidrug-resistant Gram-negative bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoferrin | Experimental | Patients in the prophylaxis group will receive, in addition to standard treatment, a orodispersible formulation of bovine lactoferrin or bLF (Mosiac®) at the standard dose of 200 mg/day, in single administration, from the start of chemotherapy treatment and for the duration of the risk period. |
|
| Placebo | Placebo Comparator | Patients in the control group will receive only the standard treatment provided by their clinical center with placebo added from the start of chemo/radiotherapy treatment and throughout the duration of the risk period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin Bovine | Dietary Supplement | In addition to standard treatment, a gold-soluble formulation of bovine lactoferrin or bLF (Mosiac®) at the standard dose of 200 mg/day, in single administration, from the start of chemo/radiotherapy treatment and throughout the risk period. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Presence or absence of febrile neutropenia or sepsis | From treatment up to 90 days |
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Inclusion Criteria:
Patients with severe neutropenia lasting >7 days:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo Pavia | Pavia | Italy | 27100 | Italy |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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Randomized, double-blind, placebo-controlled study
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |