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

NCT03399331 | Completed Phase 1

• 1 other identifier: NUR.LB.08
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Oral mucositis (OM) is a significant complication occurring in approximately 40% of patients on chemotherapy regimens. Ulcerative lesions of OM can be very painful, with negative impact on diet, oral hygiene, and quality of life. Although a wide variety of agents have been tested to prevent OM or reduce its severity, none have provided conclusive evidence. Objectives of this study will be: to determine the efficacy of honey or olive oil on the severity and pain of OM compared to placebo (standard care) and, (2) to assess which of the two interventions is more beneficial. Research Questions:

1. 1.Children/adults who receive honey (group 1) or olive oil (group 2) will have less severe OM compared to the control group (Severity is measured by recovery time from OM and is the primary outcome)
2. 2.Children/adults who receive honey (group 1) OR Olive oil (group 2) will have less pain than the control group. (Severity of pain is the secondary outcome Methods: A randomized controlled study (RCT) will be used to evaluate the effect of topical application of honey or olive oil, in the treatment of chemotherapy-related OM in 60 participants with OM. The primary outcome will be the severity of mucositis, assessed by four trained nurses blinded to the study group using the scale presented by the World Health Organization (WHO). The secondary outcome will be pain also assessed by the four trained nurses on the visual analogue scale ort eh Wong Faces scale.

Conditions

Oral Mucositis; Leukemia

Keywords

honey, olive oil, oral mucositis, pain

Outcome Measures

Primary Outcomes (1)

• The severity of Oral mucositis

  Defined as the number of days from the initiation of treatment until healing or day 7 assessed by four trained nurses on a daily basis and who are blinded to the study group using the World Health Organization (WHO) scale. The WHO scale is based upon the ability to eat and drink combined with objective signs of mucositis, namely erythema and ulceration. Visualisation of the oral cavity is critical for scoring, as the presence of oral ulcers delineates a WHO mucositis grade which ranges from 0 to 4 where higher scores correspond to worse mucositis. The PI will establish inte-rater reliability with the four nurses by assessing patients on the WHO scale. Each nurse will conduct the assessment and compare her/his results with the PI, this will be done until a reliability of \>. 80 is achieved. Reliability will be done before the study begins and then every month until the completion of the study.

  7 days or until healing or Discharge

Secondary Outcomes (1)

• Pain as reported by children

  7 days or until healing or Discharge

Study Arms (3)

group 1

EXPERIMENTAL

Efficacy of Manuka honey on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial.

Dietary Supplement: Manuka honey

Group 2

EXPERIMENTAL

Efficacy of olive oil on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial.

Dietary Supplement: olive oil

Group 3

PLACEBO COMPARATOR

The control group at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine

Combination Product: Control group

Interventions

Manuka honey DIETARY_SUPPLEMENT

5 for children or 10cc of honey for adults was ordered directly from a New Zealand company

group 1

olive oil DIETARY_SUPPLEMENT

5 cc of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon will be given.

Group 2

Control group COMBINATION_PRODUCT

Control at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine).

Group 3

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Absence of any home remedy for mucositis
• Patients with grades 1-3 OM based on the WHO grading system.

You may not qualify if:

• Patients under non- intensive chemotherapeutic treatment.
• Presence of advanced or severe periodontitis (patients with periodontal pockets of 6mm or more).
• Patients with a cognitive disability which my no enable them to assess their pain
• History of allergy to honey or olive oil.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Azusa Pacific University: collaborator
• Daisy Foundation: collaborator

Study Sites (1)

American Univeristy of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (8)

• Al Jaouni SK, Al Muhayawi MS, Hussein A, Elfiki I, Al-Raddadi R, Al Muhayawi SM, Almasaudi S, Kamal MA, Harakeh S. Effects of Honey on Oral Mucositis among Pediatric Cancer Patients Undergoing Chemo/Radiotherapy Treatment at King Abdulaziz University Hospital in Jeddah, Kingdom of Saudi Arabia. Evid Based Complement Alternat Med. 2017;2017:5861024. doi: 10.1155/2017/5861024. Epub 2017 Feb 7.

  PMID: 28270852 BACKGROUND

• Kobya Bulut H, Guducu Tufekci F. Honey prevents oral mocositis in children undergoing chemotherapy: A quasi-experimental study with a control group. Complement Ther Med. 2016 Dec;29:132-140. doi: 10.1016/j.ctim.2016.09.018. Epub 2016 Sep 19.

  PMID: 27912937 BACKGROUND

• Xu JL, Xia R, Sun ZH, Sun L, Min X, Liu C, Zhang H, Zhu YM. Effects of honey use on the management of radio/chemotherapy-induced mucositis: a meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1618-1625. doi: 10.1016/j.ijom.2016.04.023. Epub 2016 Sep 3.

  PMID: 27600797 BACKGROUND

• Jayalekshmi JL, Lakshmi R, Mukerji A. Honey on oral mucositis: A Randomized controlled trial. Gulf J Oncolog. 2016 Jan;1(20):30-7.

  PMID: 27050177 BACKGROUND

• Cho HK, Jeong YM, Lee HS, Lee YJ, Hwang SH. Effects of honey on oral mucositis in patients with head and neck cancer: A meta-analysis. Laryngoscope. 2015 Sep;125(9):2085-92. doi: 10.1002/lary.25233. Epub 2015 Mar 16.

  PMID: 25778825 BACKGROUND

• Hawley P, Hovan A, McGahan CE, Saunders D. A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Support Care Cancer. 2014 Mar;22(3):751-61. doi: 10.1007/s00520-013-2031-0. Epub 2013 Nov 13.

  PMID: 24221577 BACKGROUND

• 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 BACKGROUND

• Song JJ, Twumasi-Ankrah P, Salcido R. Systematic review and meta-analysis on the use of honey to protect from the effects of radiation-induced oral mucositis. Adv Skin Wound Care. 2012 Jan;25(1):23-8. doi: 10.1097/01.ASW.0000410687.14363.a3.

  PMID: 22218067 BACKGROUND

MeSH Terms

Conditions

Stomatitis; Leukemia; Pain

Interventions

Olive Oil; Control Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pain scores of the oral mucosa will be conducted twice a daily for study purposes. The patients will be assessed by their RNs for pain which is documented in the patient charts twice per day in the morign and in the evening (even in the absence of pain), the nurses will have no knowlegde of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, leader for Research

Model Details: three groups randomized using a computer generted number sequence

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: July 10, 2017
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

LE (1)