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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431729
• Other study ID #: honey propolis 421
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2011
• Last updated: September 19, 2011
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
Egypt	Hematology - Oncology, Children's Hospital, Ain Shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
mamdouh abdulmaksoud abdulrhman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Recovery time" , defined as the number of days from initiation of treatment to when complete healing of all ulcers will occur.		10 days	Yes

External Links

•   mamdouh565@hotmail.com