Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03399331
• Date of registration: 08/01/2018
• Prospective Registration: No
• Primary sponsor: American University of Beirut Medical Center
• Public title: Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy
• Scientific title: "The Efficacy of Honey or Olive Oil on the Severity and Pain of Oral Mucositis Compared to Placebo (Standard Care) in Children With Leukemia Receiving Intensive Chemotherapy
• Date of first enrolment: July 10, 2017
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03399331
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Lebanon

Contacts

• Name: lina K Badr, PhD

• Name: MD

Key inclusion & exclusion criteria

Inclusion Criteria:

The following are the inclusion criteria:

1. Children/Adults with leukemia (ALL, AML) receiving intensive (high dose) chemotherapy
treatment such as myeloablative, doxorubicin or methotrexate during induction,
consolidation and re-induction therapy.

2. Absence of any home remedy for mucositis

3. Patients with grades 1-3 OM based on the WHO grading system.

Exclusion Criteria:

1. Patients under non- intensive chemotherapeutic treatment.

2. Presence of advanced or severe periodontitis (patients with periodontal pockets of 6mm
or more).

3. Patients with a cognitive disability which my no enable them to assess their pain

4. History of allergy to honey or olive oil.



Age minimum: 5 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Oral Mucositis

Leukemia

Intervention(s)

Dietary Supplement: Manuka honey

Combination Product: Control group

Dietary Supplement: olive oil

Primary Outcome(s)

severity of OM [Time Frame: 7 days or until healing or Discharge]

Secondary Outcome(s)

pain [Time Frame: 7 days or until healing or Discharge]

Secondary ID(s)

NUR.LB.08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Daisy Foundation

Azusa Pacific University