Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001927213
Ethics application status
Approved
Date submitted
24/11/2018
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 manage children's chemotherapy induced oral mucositis.
Scientific title
Evaluation of the Effectiveness of Olive oil and Aloe-vera in Management of Chemotherapy Induced Oral Mucositis in Children with Acute Lymphoblastic Leukemia.
Secondary ID [1] 296703 0
None.
Universal Trial Number (UTN)
U1111-1224-5293
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Mucositis 310553 0
Condition category
Condition code
Oral and Gastrointestinal 309264 309264 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Skin 309265 309265 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 who have grade 3 or 4 according to WHO Oral Mucositis Grading Scale will apply theses topical agents for ten days to assess the reduction of the grade of oral mucositis

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.

The follow-up will be after ten days from the application by two experienced external investigators (Oral Medicine specialists).
The investigator will assess oral mucositis according to WHO Oral Mucositis Grading Scale.
Intervention code [1] 313015 0
Treatment: Drugs
Comparator / control treatment
sodium bicarbonate solution
Control group
Active

Outcomes
Primary outcome [1] 308238 0
assessment of Oral Mucosa.
A blinded investigator using WHO Oral Mucositis Grading Scale will do the measure.
Timepoint [1] 308238 0
Baseline and re-evaluate in one interval stage.
the follow-up will be ten days after the intervention.
Endpoint will be ten days after the intervention.
Secondary outcome [1] 354355 0
Patient discomfort.
Patient discomfort will be assessed using Wong-Baker Faces scale.
Timepoint [1] 354355 0
Baseline: patient discomfort will be assessed before the intervention.
Endpoint will be 10 days after the intervention to assess if it will make the patient more comfort.

Eligibility
Key inclusion criteria
Inclusion Criteria of participants:
1. Children with acute lymphoblastic leukemia who aged between 4-6 years.
2. Have grade 3 or 4 oral mucositis according to WHO Oral Mucositis Grading Scale.
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known sensitivity to olive oil or Aloe-vera.

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
Sample size was calculated using G-power 3.1 software. 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 35 patients were required to demonstrate an effect size (0.4) in the average proportion of managed oral mucositis.
Sample size will be raised to 45 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
10/02/2019
Actual
Date of last participant enrolment
Anticipated
10/03/2019
Actual
Date of last data collection
Anticipated
20/03/2019
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 21066 0
Syrian Arab Republic
State/province [1] 21066 0
Damascus

Funding & Sponsors
Funding source category [1] 301282 0
University
Name [1] 301282 0
Damascus University
Country [1] 301282 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] 300931 0
None
Name [1] 300931 0
Address [1] 300931 0
Country [1] 300931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302026 0
Ethical and Scientific Committee of dental research of Damascus University
Ethics committee address [1] 302026 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
Ethics committee country [1] 302026 0
Syrian Arab Republic
Date submitted for ethics approval [1] 302026 0
26/04/2018
Approval date [1] 302026 0
21/05/2018
Ethics approval number [1] 302026 0

Summary
Brief summary
Oral mucositis is a significant complication occurring in most of patients on chemotherapy regimens. 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 manage 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 managing chemotherapy induced oral mucositis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88882 0
Dr Muaaz Alkhouli
Address 88882 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 88882 0
Syrian Arab Republic
Phone 88882 0
+963966133383
Fax 88882 0
Email 88882 0
[email protected]
Contact person for public queries
Name 88883 0
Dr Muaaz Alkhouli
Address 88883 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 88883 0
Syrian Arab Republic
Phone 88883 0
+963966133383
Fax 88883 0
Email 88883 0
[email protected]
Contact person for scientific queries
Name 88884 0
Dr Muaaz Alkhouli
Address 88884 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 88884 0
Syrian Arab Republic
Phone 88884 0
+963966133383
Fax 88884 0
Email 88884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.