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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Chemotherapy Treatment; Sepsis; Febrile Neutropenia (FN)

Treatments: Dietary Supplement: Lactoferrin Bovine

Study type: Interventional

Funder types: Other

Identifiers

NCT07113314

Lactoferrin 3527/2016

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

Lactoferrin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lactoferrin Bovine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Lactoferrin Bovine