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

Brief summary (registry, in English)

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. 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. 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. The relevance of this study lies in the possibility of challenging nurses in regard to the problem of OM and in proving a possible herbal cure that may influence clinical practice. Data analysis: The characteristics of the three groups will be described using mean and SD, frequencies and percentages. Baseline differences between the two groups will be tested using ANOVA for continuous data, and the Chi-square for categorical data. Kruskall-Wallis (chi square) test will be used to find the association group assignment and WHO grades of OM and ANOVA and RANOVA tests will be used to find the association between group assignment and the pain scores. Bonferroni tests will be conducted to explore which of the three groups has the better outcomes.

What you commit to

• Study type: Interventional · Phase 1
• Participants enrolled: 45
• From 10 Jul 2017 to the primary completion date, 1 Dec 2021
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 5 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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