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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
mamdouh abdulmaksoud abdulrhman, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01431729
First received: September 8, 2011
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Other: honey, hope,mucositis
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis: a Randomized Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • "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 ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: honey,propolis,olive oil, mucositis

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01431729

Locations
Egypt
Hematology - Oncology, Children's Hospital, Ain Shams University
Cairo, Abbasia, Egypt
Sponsors and Collaborators
mamdouh abdulmaksoud abdulrhman
Investigators
Principal Investigator: Mamdouh Abdulrhman, professor professor
  More Information

Additional Information:
No publications provided by Ain Shams University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: mamdouh abdulmaksoud abdulrhman, professor of pediatrics, faculty of medicine, ain shams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT01431729     History of Changes
Other Study ID Numbers: honey propolis 421
Study First Received: September 8, 2011
Last Updated: September 19, 2011
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Propolis
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014