Chemotherapy Treatment, Febrile Neutropenia (FN), Sepsis
Conditions
Keywords
chemotherapy treatment, Sepsis, Febbrile neutropenia
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.
Interventions
DIETARY_SUPPLEMENTLactoferrin 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.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, double-blind, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | From treatment up to 90 days | Presence or absence of febrile neutropenia or sepsis |
Countries
Italy
Outcome results
None listed