The Effects of Honey on Febrile Neutropenia in Children With Acute Lymphoblastic Leukemia

Overview

Febrile neutropenia (FN) is a common and serious side effect of chemotherapy. Current management of FN is expensive and may induce side effects. Honey is a natural substance produced by honeybees. It possesses antioxidant, antimicrobial and anticancer effects. In addition, honey is not expensive. The aim of this study was to evaluate the effects of 12-week honey consumption on children with acute lymphoblastic leukemia (ALL) particularly with regards of FN episodes. This randomized crossover clinical trial included 40 patients of both sexes, aged 2.5 to 10 years. They were randomized into two equal groups [intervention to control (I/C) and control to intervention (C/I)]. The dietary intervention was 12-week honey consumption in a dose of 2.5g//kg body weight per dose twice weekly.

Full Title of Study: “The Effect of Honey on Episodes of Febrile Neutropenia in Children With Acute Lymphoblastic Leukemia: A Randomized Crossover Open- Labeled Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2013

Detailed Description

This was a crossover randomized study that took place at the Children Hospital of Ain Shams University-Cairo-Egypt, from March 2011 to August 2013. The patients were recruited from the Hematology-Oncology Clinic of the hospital. All patients > 2 years of age with acute lymphoblastic leukemia (ALL), treated according to the Modified CCG 1991 protocol for standard- risk ALL and on maintenance therapy, were candidates for this study. Patients with diabetes mellitus (DM) and patients who had febrile neutropenia at the time enrollment were excluded from the study. A crossover design (two 12-week intervention periods) was used to measure honey effects. The subjects were randomized into two equal groups (group A or control to intervention [C/I] group and group B or intervention to control [I/C] group). A computer-generated list of random numbers was used to allocate participants equally in each group. Since there was no previous similar study, a pre-specified sample size was not determined. The subjects in the I/C group consumed 2 ml (2.5 g) honey/kg body weight/dose twice weekly in the first 12-week period (period 1), while the subjects in the C/I group did not receive honey as a control in the period 1. After period 1, the subjects of each group exchanged their protocol for the following 12-week period (period 2). To the investigators knowledge, laboratory tests for measurement of levels of honey in blood or tissues are not yet available. Therefore, to ensure compliance to honey intake, each patient consumed the calculated dose of honey under visual supervision of the researcher. Each calculated dose of honey was dissolved in water and then ingested by the patient. The honey used in this study was an Egyptian clover honey of a carbohydrate content of 78.4 g/100 g, pH of 3.7 and a moisture content of 18.8%. The physicochemical characteristics of the honey used in the study are detailed in supplementary table 1 (17). The primary outcome measure was febrile neutropenia in terms of frequency and duration of hospital stay. The secondary outcome measures were hemoglobin (Hb) level, total leucocytic count (TLC), absolute neutrophil count (NE) and platelet count (PLT). Blood count was performed for all patients on a weekly basis. All measures were analyzed in participants at baseline (0 week), the end of the 12th week (crossover) and the end of the 24th week (end point). All patients who developed FN during the study were admitted to the hospital and received an empirical combination of intravenous antibiotic therapy consisting of piperacillin (200mg/kg/24hr, divided q 6hr) and amikacin (20mg/kg q24hr). An informed consent was obtained from at least one parent of each child before enrollment, and the study was approved by the local Ethics Committee of the Pediatric Department of Ain Shams University Hospitals.

Interventions

  • Dietary Supplement: Honey
    • The subjects in the I/C group consumed 2 ml (2.5 g) honey/kg body weight/dose twice weekly in the first 12-week period (period 1), while the subjects in the C/I group did not receive honey as a control in the period 1. After period 1, the subjects of each group exchanged their protocol for the following 12-week period (period 2).

Clinical Trial Outcome Measures

Primary Measures

  • Febrile neutropenia: composite (febrile neutropenia in terms of frequency and duration of hospital stay)
    • Time Frame: 3 months
    • The measure is composite (febrile neutropenia in terms of frequency and duration of hospital stay)

Participating in This Clinical Trial

Inclusion Criteria

  • All patients > 2 years of age with acute lymphoblastic leukemia (ALL), treated according to the Modified CCG 1991 protocol for standard- risk ALL and on maintenance therapy Exclusion Criteria:

  • Patients with diabetes mellitus (DM) and patients who had febrile neutropenia at the time enrollment were excluded from the study.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: mamdouh abdulmaksoud abdulrhman, professor of pediatrics – Ain Shams University
  • Overall Official(s)
    • Ahmad A Hamed, Dr, Principal Investigator, Pediatric department, Faculty of Medicine, Ain Shams University
    • Sahar A Mohamed, Dr, Principal Investigator, Faculty of Medicine, El-Azhar University
    • Nouran A Hassanen, M.B.B.Ch, Principal Investigator, Pediatric department, Faculty of Medicine, Ain Shams University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.