Comparing treatments for oral mucositis in children undergoing chemotherapy
Official title: The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial
Run by Burdur Mehmet Akif Ersoy University · NCT06525402 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Burdur Mehmet Akif Ersoy University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Isparta) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | September 25, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT06525402 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6-18 years who are hospitalized for chemotherapy and are willing to participate.
✕Probably not a fit
Patients with pre-existing oral mucositis or those receiving concurrent treatments that may interfere with the study will not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on oral care for mucositis, the specific combination of treatments being tested in this study is novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Copaiba Mouthwash with Low-Level Laser Therapy to Prevent Mouth Sores After Stem Cell Transplant
This phase 2 trial tests whether a copaíba-based mouthwash, used four times daily, can help prevent oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation.
-
Chlorophyllin to reduce mouth sores before allogeneic stem cell transplant
This phase II study tests whether taking chlorophyllin by mouth can lower the chances and severity of mouth ulcers in patients aged 12–65 undergoing radiation-based conditioning before a first allogeneic stem cell transplant.
-
BupiZenge vs Lidocaine for mouth pain from oral mucositis in head and neck cancer
A phase 3 trial tests whether the BupiZenge lozenge provides better pain relief than lidocaine for mouth sores caused by radiation in head and neck cancer patients.
-
Adding silibinin to standard daunorubicin or idarubicin therapy for newly diagnosed non‑M3 acute myeloid leukemia
This trial will test whether adding silibinin (a liver‑protecting compound) to standard daunorubicin or idarubicin chemotherapy helps people with newly diagnosed non‑M3 acute myeloid leukemia.
-
Ozone gas plus biomimetic toothpaste and mouthwash to treat cancer therapy mouth sores
This trial will test whether adding a biomimetic toothpaste and mouthwash to ozone gas therapy helps adults with chemo- or radiotherapy-induced mouth sores heal faster and have less pain.
-
High-level laser therapy for oral mucositis in children receiving hematopoietic stem cell transplant
This trial tests whether high-level laser therapy can reduce the pain and severity of oral mucositis in children undergoing hematopoietic stem cell (bone marrow) transplantation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.