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

Sponsor

mamdouh abdulmaksoud abdulrhman (Other)

Overall Status

Completed

CT.gov ID

NCT01431729

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis	Other: honey, hope,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.

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology - Oncology, Children's Hospital, Ain Shams University	Cairo	Abbasia	Egypt

Sponsors and Collaborators

mamdouh abdulmaksoud abdulrhman

Investigators

Principal Investigator: Mamdouh Abdulrhman, professor, professor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

mamdouh565@hotmail.com

Publications

None provided.

Responsible Party:

mamdouh abdulmaksoud abdulrhman, professor of pediatrics, faculty of medicine, ain shams university, Ain Shams University

ClinicalTrials.gov Identifier:

NCT01431729

Other Study ID Numbers:

honey propolis 421

First Posted:

Sep 12, 2011

Last Update Posted:

Sep 21, 2011

Last Verified:

Sep 1, 2011

Additional relevant MeSH terms:

Mucositis

Stomatitis

Propolis

Study Results

No Results Posted as of Sep 21, 2011