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Trial registered on ANZCTR


Registration number
ACTRN12618001931268
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
28/11/2018
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical agents to prevent children's chemotherapy induced oral mucositis.
Scientific title
Evaluation of the Effectiveness of Olive oil and Aloe-vera in Prevention of Chemotherapy Induced Oral Mucositis in Children with Acute Lymphoblastic Leukemia.
Secondary ID [1] 296668 0
None
Universal Trial Number (UTN)
U1111-1223-9672
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral mucositis 310509 0
Condition category
Condition code
Oral and Gastrointestinal 309222 309222 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Skin 309262 309262 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children with Acute Lymphoblastic Leukemia (ALL) will be divided into 3 groups:
Group 1: olive oil taken directly from a local distributor in Syria. It will be stored in dark containers at room temperature through the study phase.
Group 2: Aloe-vera solution. It will be stored in dark containers at 4°C through the study phase.
Group 3: Sodium bicarbonate 5% solution as a control group.

Children will start applying these agents topically two days before chemotherapy starts and for two months with the help of Hospital's nurses and the parents.

The method of applying the agents for all participants:
the intervention will be done at Children Univesrity Hospital in Damascus.
Children will be instructed to brush their teeth before the application, then the topical application will be two times daily by a sterilized disposable spongeous stick. For each application a new spongeous stick will be immersed into one of the agents and 5 ml will be applied to tongue, buccal mucosa, lips and hard palate by the help of the Hospital's nurses and the parents who will be informed that participants are not allowed to eat or drink for one hour after the application.
Each participant will be supplied by a checklist paper posted in his/her room and the nurses will do two checks each day(one check for each application) in order to to monitor adherence of participants to the intervention. in addition, the bottles used to supply the agents are 200ml bottles, so after 20 days the bottle should need to bo refilled again becaues 5 ml will be used at each application.

The follow-up will be once weekly for eight weeks (during the induction and consolidation phases of chemotherapy) by two experienced external investigators (Oral Medicine specialists).
The investigator will assess oral mucositis according to WHO Oral Mucositis Grading Scale. the follow-up will be weekly to assess if the intervention will delay oral mucositis appearance also.
Intervention code [1] 312978 0
Prevention
Comparator / control treatment
sodium bicarbonate solution.
Control group
Active

Outcomes
Primary outcome [1] 308186 0
assessment of Oral Mucosa.
A blinded investigator using WHO Oral Mucositis Grading Scale will do the measure.
Timepoint [1] 308186 0
Baseline: before the chemotherapy starts.
Follow-up will be weekly for 8 interval timepoints to assess if the intervention will delay oral mucositis appearance.
Endpoint will be 8 weeks after the initiation of chemotherapy.
Secondary outcome [1] 354200 0
Change in body weight.
this will be done by measuring the weight in kilogram of each participant weekly using an electronic scale digital body weight balance.
This will be assessed by a blinded investigator.
Timepoint [1] 354200 0
Baseline: before the chemotherapy starts.
Follow-up will be weekly for 8 interval timepoints to assess body weight change of each participant during the study phase.
Endpoint will be 8 weeks after the initiation of chemotherapy.

Eligibility
Key inclusion criteria
Inclusion Criteria of participants:
1. Children with acute lymphoblastic leukemia who aged between 4-6 years.
2. Have not received chemotherapy or radiotherapy before sampling.
3. Intact oral mucosa.
Minimum age
4 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known sensitivity to olive oil or Aloe-vera.
2. Presence of any gingival or oral ulceration or mucositis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using arandomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample size was calculated using g-power 3.1 software. The significance level was set at 0.05 and the power of the study was set to be 0.80.
Based on a one-way Anova test, it was estimated that 28 patients were required to demonstrate an effect size (0.4) in the average proportion of oral mucositis prevention..
Sample size will be raised to 36 patients to avoid the negative effect of the possible drop rate.

Statistical analyses will be performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA).

- The normality of distribution of the date will be verified by Kolmogorov-Smirnov normality test.
- If the data were normally distributed, One-way Anova test will be applied. Deviations from baseline will be tested for significance with the Bonferroni post hoc test.
- if the data were not normally distributed, kruskal wallis test will be applied. Deviations from baseline will be tested for significance with the Wilcoxon Signed Rank Matched Pairs Test.
- Interrater reliability will be tested using Cohen's Kappa measure.
- The level of significance will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21055 0
Syrian Arab Republic
State/province [1] 21055 0
Damascus

Funding & Sponsors
Funding source category [1] 301247 0
University
Name [1] 301247 0
Damascus University
Address [1] 301247 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
Country [1] 301247 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 300882 0
None
Name [1] 300882 0
None
Address [1] 300882 0
None
Country [1] 300882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301986 0
Ethical and Scientific Committee of dental research of Damascus University
Ethics committee address [1] 301986 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
Ethics committee country [1] 301986 0
Syrian Arab Republic
Date submitted for ethics approval [1] 301986 0
22/04/2018
Approval date [1] 301986 0
21/05/2018
Ethics approval number [1] 301986 0

Summary
Brief summary
Oral mucositis is a significant complication occurring in most of patients on chemotherapy regimens. this complication can appear about two weeks after chemotherapy starts. Ulcerative lesions of oral mucositis can be very annoying, with negative impact on diet, oral hygiene, and quality of life. Although a wide variety of agents have been tested to prevent oral mucositis or reduce its severity, none have provided conclusive evidence.
The null hypothesis tested is that neither olive oil nor Aloe-vera is effective in preventing chemotherapy induced oral mucositis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88770 0
Dr Muaaz Alkhouli
Address 88770 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 88770 0
Syrian Arab Republic
Phone 88770 0
+963966133383
Fax 88770 0
Email 88770 0
muaaz.alkhouli@outlook.com
Contact person for public queries
Name 88771 0
Dr Muaaz Alkhouli
Address 88771 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 88771 0
Syrian Arab Republic
Phone 88771 0
+963966133383
Fax 88771 0
Email 88771 0
muaaz.alkhouli@outlook.com
Contact person for scientific queries
Name 88772 0
Dr Muaaz Alkhouli
Address 88772 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 88772 0
Syrian Arab Republic
Phone 88772 0
+963966133383
Fax 88772 0
Email 88772 0
muaaz.alkhouli@outlook.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
No Results