Prophylaxis of Febrile Neutropenia With Lactoferrin in Oncohematologic Children Undergoing Induction Chemotherapy
NCT ID: NCT07113314
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2016-10-06
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Lactoferrin
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.
Lactoferrin Bovine
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.
Placebo
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.
Lactoferrin Bovine
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.
Interventions
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Lactoferrin Bovine
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.
Eligibility Criteria
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Inclusion Criteria
* non-High Risk Acute Lymphoblastic Leukemia ( ALL) under induction treatment
* Acute Myeloid Leukemia (AML) (first two cycles of treatment)
* B cell - non Hodgkin Lymphoma (NHL) Ability to take oral lactoferrin therapy and perform the diagnostic tests established by the protocol
Exclusion Criteria
* Past history of colonization/infection by multidrug-resistant pathogens
* Inability to take LF by mouth
* Refusal to participate in the study
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Marco Zecca
Principal Investigator
Locations
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Fondazione IRCCS Policlinico San Matteo Pavia
Pavia, Italy, Italy
Countries
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Other Identifiers
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Lactoferrin 3527/2016
Identifier Type: -
Identifier Source: org_study_id
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