Prophylaxis of Febrile Neutropenia With Lactoferrin in Oncohematologic Children Undergoing Induction Chemotherapy

Fondazione IRCCS Policlinico San Matteo di Pavia160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

160

Conditions

Febrile Neutropenia (FN)Sepsis Chemotherapy Treatment

Interventions

Lactoferrin BovineDIETARY_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.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients with severe neutropenia lasting \>7 days: * 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: * Previous chemotherapy treatments * Past history of colonization/infection by multidrug-resistant pathogens * Inability to take LF by mouth * Refusal to participate in the study

Locations (1)

Fondazione IRCCS Policlinico San Matteo Pavia

Pavia, Italy, Italy

Outcomes

Primary Outcomes

Primary Outcome

Presence or absence of febrile neutropenia or sepsis

Time frame: From treatment up to 90 days

Data from ClinicalTrials.gov

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