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

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ClinicalTrials.gov Identifier: NCT02272673
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
mamdouh abdulmaksoud abdulrhman, Ain Shams University

Tracking Information
First Submitted Date October 19, 2014
First Posted Date October 23, 2014
Last Update Posted Date October 24, 2014
Study Start Date March 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2014)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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
Condition Acute Lymphoblastic Leukemia
Intervention 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).
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 22, 2014)
40
Original Actual Enrollment Same as current
Actual Study Completion Date September 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT02272673
Other Study ID Numbers 1/2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party mamdouh abdulmaksoud abdulrhman, Ain Shams University
Study Sponsor Ain Shams University
Collaborators Not Provided
Investigators
Principal Investigator: Ahmad A Hamed, Dr Pediatric department, Faculty of Medicine, Ain Shams University
Principal Investigator: Sahar A Mohamed, Dr Faculty of Medicine, El-Azhar University
Principal Investigator: Nouran A Hassanen, M.B.B.Ch Pediatric department, Faculty of Medicine, Ain Shams University
PRS Account Ain Shams University
Verification Date October 2014