Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03399331|
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
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.
- 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)
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Oral Mucositis Leukemia||Dietary Supplement: Manuka honey Dietary Supplement: olive oil Combination Product: Control group||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official 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|
|Actual Study Start Date :||July 10, 2017|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: group 1
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
5 for children or 10cc of honey for adults was ordered directly from a New Zealand company
Experimental: Group 2
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
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.
Placebo Comparator: Group 3
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
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).
- severity of OM [ Time Frame: 7 days or until healing or Discharge ]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.
- pain [ Time Frame: 7 days or until healing or Discharge ]Pain assessed as per the institution's policy using the Visual analogue 10cm scale (VAS) or the Wong faces scale. A 0 indicates no mouth or throat pain and 10 indicates the most severe mouth or throat pain ( see appendix E in the proposal). The construct, convergent and predictive validity of the VAS and the Faces scales have been widely published (26). 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 morning and in the evening (even in the absence of pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399331
|American Univeristy of Beirut Medical Center||Recruiting|
|Contact: lina K Badr, PhD 01196132815041 email@example.com|
|Sub-Investigator: Rima Saad, MSN|
|Sub-Investigator: Rebecca El Asmar, MSN|