Actively Recruiting
The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial
Led by Burdur Mehmet Akif Ersoy University · Updated on 2025-03-26
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different oral care methods on oral mucositis, a common and painful side effect of cancer treatment, in children aged 6 to 18 years who are receiving chemotherapy. The study compares routine oral care using sodium bicarbonate with two experimental treatments: saline mouthwash and black mulberry syrup mouthwash, to understand their impact on the severity of oral mucositis during chemotherapy. Participants will be randomly divided into three groups. One group will receive routine oral care with sodium bicarbonate mouthwash, while the other two groups will receive oral care with saline or black mulberry syrup mouthwash, respectively. Oral care will be performed four times a day for 14 days. The study involves a randomized controlled design with quadruple masking. Children's oral health will be assessed using the International Child Mucositis Evaluation Scale (ChIMES) and the World Health Organization Mucositis Classification on days 1, 2, 4, 8, and 16. Neutrophil counts will also be measured during this period. Researchers will monitor changes in mucositis severity and blood counts throughout the study to evaluate treatment effects and safety during chemotherapy.
CONDITIONS
Brief Title
Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The willingness of the family and the child to participate in the study
- Parent and child have separately informed written consent form
- Be between 6-18 years old
- Receiving chemotherapy and being hospitalized for chemotherapy treatment
- Being fed orally
You will not qualify if you...
- Oral mucositis in the first intraoral evaluation
- Having diabetes
- Receiving radiotherapy
- Having a surgical procedure in the mouth and jaw area
- Receiving steroid therapy during chemotherapy treatment
- Using a method other than the methods used in the study to protect the oral mucous membrane throughout the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive oral care with either sodium bicarbonate, saline, or black mulberry syrup as a mouthwash 4 times a day for 14 days to prevent oral mucositis during chemotherapy.
Daily oral care 4 times a day
Duration - 16 days
Researchers evaluate oral mucositis severity and neutrophil counts on days 1, 2, 4, 8, and 16 to monitor treatment effects and safety.
5 assessment visits (in-person) on days 1, 2, 4, 8, and 16
Trial Site Locations
Total: 1 location
1
Isparta City Hospital
Isparta, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Selda Ateş Beşirik, Assistant Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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