Comparing treatments for oral mucositis in children undergoing chemotherapy
The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial
This study tests whether sodium bicarbonate, saline, or black mulberry syrup can help reduce mouth sores in children aged 6-18 who are getting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Burdur Mehmet Akif Ersoy University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Isparta) |
| Trial ID | NCT06525402 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of sodium bicarbonate, saline, and black mulberry syrup in reducing oral mucositis in children aged 6-18 years receiving chemotherapy. Participants will be randomly assigned to one of three groups: the control group will receive standard sodium bicarbonate treatment, while the intervention groups will receive either saline or black mulberry syrup in addition to the standard care. Oral care will be administered four times daily for 14 days, and the severity of mucositis will be assessed using established scales and neutrophil counts at multiple time points. The goal is to determine which treatment is most effective in alleviating the symptoms of oral mucositis.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-18 years who are hospitalized for chemotherapy and are willing to participate.
Not a fit: Patients with pre-existing oral mucositis or those receiving concurrent treatments that may interfere with the study will not benefit.
Why it matters
Potential benefit: If successful, this study could provide effective oral care options to improve the quality of life for children undergoing chemotherapy.
How similar studies have performed: While there have been studies on oral care for mucositis, the specific combination of treatments being tested in this study is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Isparta
- Isparta City Hospital — Isparta, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Selda Ateş Beşirik, Assistant Professor — Burdur Mehmet Akif Ersoy University
- Study coordinator: Selda Ateş Beşirik, Assistant Professor
- Email: seldaates07@gmail.com
- Phone: +905543683323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.