Not Yet RecruitingPhase 2ACTRN12618001927213

Topical agents to manage children's chemotherapy induced oral mucositis.

Evaluation of the Effectiveness of Olive oil and Aloe-vera in Management of Chemotherapy Induced Oral Mucositis in Children with Acute Lymphoblastic Leukemia.


Sponsor

Damascus University

Enrollment

45 participants

Start Date

Feb 10, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 6 Yearss

Inclusion Criteria2

  • Children with acute lymphoblastic leukemia who aged between 4-6 years.
  • Have grade 3 or 4 oral mucositis according to WHO Oral Mucositis Grading Scale.

Exclusion Criteria1

  • Known sensitivity to olive oil or Aloe-vera.

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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 tempe

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.


Locations(1)

Damascus, Syrian Arab Republic

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