Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis

Completed

• Conditions: Oral Mucositis
• Interventions: Other: honey, hope,mucositis

• Registration Number: NCT01431729
• Lead Sponsor: mamdouh abdulmaksoud abdulrhman

Brief Summary

Although, oral mucositis has been studied for many years, no available treatment has been shown to be effective in preventing or treating mucositis. Based on the observations that honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial and wound healing effects, the present study aims at evaluation of the effect of topical application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as natural products, in treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which eligible patients were randomly assigned into three equal treatment groups. Group 1 received 15 gm honey applied topically to the affected oral mucosa three times daily. Group 2 received 5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied topically to the oral mucosa three times daily. Group 3 served as control and received a 7.5% benzocaine gel applied to the areas of ulcers three times daily.

Detailed Description

All patients with ALL during the consolidation phase of treatment, and with chemotherapy-related oral mucositis grades 2 and 3 were candidates for this trial.Exclusion criteria included the presence of any of the following: (1) coexisting diabetes mellitus, (2) administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study, (3) presence of neutropenia (absolute neutrophilic count \[ANC\] ≤ 1500/mm3), (4) presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more. The primary outcome measure was the "recovery time", defined as the number of days from initiation of treatment to when complete healing of all ulcers occurred.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2011-09
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-12
• Last Update Submitted: 2011-09-19
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients with ALL during the consolidation phase of treatment, and
• with chemotherapy-related oral mucositis grades 2 and 3

Exclusion Criteria

1. coexisting diabetes mellitus,
2. administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study,
3. presence of neutropenia (absolute neutrophilic count [ANC] ≤ 1500/mm3),
4. presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mucositis	honey, hope,mucositis	-

Primary Outcome Measures

Name	Time	Method
"Recovery time" , defined as the number of days from initiation of treatment to when complete healing of all ulcers will occur.	10 days

Trial Locations

Locations (1)

Hematology - Oncology, Children's Hospital, Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt