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

NCT02272673 | Completed DMC

• 1 other identifier: 1/2011
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

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

  The measure is composite (febrile neutropenia in terms of frequency and duration of hospital stay)

  3 months

Interventions

Honey DIETARY_SUPPLEMENT

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).

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Pediatric Department, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Honey

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pediatrics

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: October 23, 2014
• Study Start: March 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2014
• Last Updated: October 24, 2014

Record last verified: 2014-10

Locations

EG (1)