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

NCT07113314 | Completed DMC

• 1 other identifier: Lactoferrin 3527/2016
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Febrile Neutropenia (FN); Sepsis; Chemotherapy Treatment

Keywords

chemotherapy treatment; Sepsis; Febbrile neutropenia

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Presence or absence of febrile neutropenia or sepsis

  From treatment up to 90 days

Study Arms (2)

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.

Dietary Supplement: Lactoferrin Bovine

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.

Dietary Supplement: Lactoferrin Bovine

Interventions

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.

Lactoferrin; Placebo

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previous chemotherapy treatments
• Past history of colonization/infection by multidrug-resistant pathogens
• Inability to take LF by mouth
• Refusal to participate in the study

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo Pavia

Pavia, Italy, 27100, Italy

Location

MeSH Terms

Conditions

Febrile Neutropenia; Sepsis

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 8, 2025
• Study Start: October 6, 2016
• Primary Completion: March 3, 2018
• Study Completion: December 15, 2022
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

IT (1)