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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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.
    


Study Type

Observational


Primary Outcome

Febrile neutropenia: composite (febrile neutropenia in terms of frequency and duration of hospital stay)


Condition

Acute Lymphoblastic Leukemia

Intervention

Honey


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

40

Start Date

March 2011

Completion Date

September 2014

Primary Completion Date

August 2013

Eligibility Criteria

        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

All

Ages

2 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Ahmad A Hamed, Dr, , 

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT02272673

Organization ID

1/2011


Responsible Party

Principal Investigator

Study Sponsor

Ain Shams University


Study Sponsor

Ahmad A Hamed, Dr, Principal Investigator, Pediatric department, Faculty of Medicine, Ain Shams University


Verification Date

October 2014