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

September 19, 2011 updated by: mamdouh abdulmaksoud abdulrhman

Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis: a Randomized Controlled Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt
        • Hematology - Oncology, Children's Hospital, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients were randomly allocated by a computer-generated list of random numbers to be assigned into one of three treatment groups; 30 patients each. Group (1) received an empirical dose of 15 gm honey applied topically to the affected oral mucosa three times daily until healing or for 10 days, which ever comes first. Group (2) received an empirical dose of 5 gm of a 4:2:1 mixture of honey, olive oil-propolis extract and beeswax (HOPE) applied topically to the oral mucosa three times daily until healing or for 10 days, which ever comes first. Group (3) served as controls and received benzocaine 7.5% gel applied topically to areas of ulcers three times daily.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mucositis
Other: honey, hope,mucositis
Eligible patients were randomly allocated by a computer-generated list of random numbers to be assigned into one of three treatment groups; Group (1) received an empirical dose of 15 gm honey applied topically to the affected oral mucosa three times daily until healing or for 10 days, which ever comes first. Group (2) received an empirical dose of 5 gm of a 4:2:1 mixture of honey, olive oil-propolis extract and beeswax (HOPE) applied topically to the oral mucosa three times daily until healing or for 10 days, which ever comes first. Group (3) served as controls and received benzocaine 7.5% gel applied topically to areas of ulcers three times daily.
Other Names:
  • honey,propolis,olive oil, mucositis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

mamdouh abdulmaksoud abdulrhman

Investigators

  • Principal Investigator: Mamdouh Abdulrhman, professor, professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (Estimate)

September 12, 2011

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 19, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • honey propolis 421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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