NCT07113314

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

Phase II Study for Prophylaxis of Febrile Neutropenia by Supplementation With Lactoferrin in Oncohematologic Children Undergoing High-intensity Chemotherapy Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2016-10-06
• Primary completion: 2018-03-03
• Completion: 2022-12-15
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: Italy