None listed
Conditions
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.
Interventions
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
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.
Sponsors
Damascus University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 6 Years
Healthy volunteers
No
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.
Exclusion criteria
Known sensitivity to olive oil or Aloe-vera.
Outcome results
None listed