None listed
Conditions
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.
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 will start applying these agents topically two days before chemotherapy starts and for two months wit
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.
Sponsors
Damascus University
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
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 not received chemotherapy or radiotherapy before sampling. 3. Intact oral mucosa.
Exclusion criteria
1. Known sensitivity to olive oil or Aloe-vera. 2. Presence of any gingival or oral ulceration or mucositis.
Outcome results
None listed