Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis
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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 |
- "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 |
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.
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| Egypt | |
| Hematology - Oncology, Children's Hospital, Ain Shams University | |
| Cairo, Abbasia, Egypt | |
| 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:
|
Stomatitis Mucositis Mouth Diseases Stomatognathic Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Propolis Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013