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

NCT01431729 | Completed DMC

• 1 other identifier: honey propolis 421
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

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

  10 days

Study Arms (1)

mucositis

Other: honey, hope,mucositis

Interventions

honey, hope,mucositis OTHER

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.

Also known as: honey,propolis,olive oil, mucositis

mucositis

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• mamdouh abdulmaksoud abdulrhman: lead

Study Sites (1)

Hematology - Oncology, Children's Hospital, Ain Shams University

Cairo, Abbasia, Egypt

Location

Related Publications (1)

• Abdulrhman M, Elbarbary NS, Ahmed Amin D, Saeid Ebrahim R. Honey and a mixture of honey, beeswax, and olive oil-propolis extract in treatment of chemotherapy-induced oral mucositis: a randomized controlled pilot study. Pediatr Hematol Oncol. 2012 Apr;29(3):285-92. doi: 10.3109/08880018.2012.669026.

  PMID: 22475306 DERIVED

Related Links

• mamdouh565@hotmail.com

MeSH Terms

Conditions

Stomatitis

Interventions

Honey

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mamdouh Abdulrhman, professor

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor of pediatrics, faculty of medicine, ain shams university

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 12, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

EG (1)