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Recruiting Not applicable

Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy

NCT06525402 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-01-30
Last updated
2026-09-30

Condition(s) studied

Oral MucositisChemotherapy Effect

Investigational drug(s) / intervention(s)

Sodium Bicarbonate Group (Usual care)Saline GroupBlack Mulberry Syrup Group

Sodium Bicarbonate Group (Usual care): In the clinic where the research was conducted, a guideline is routinely applied for the care of oral mucositis in line with the stages of oral mucositis. Sodium bicarbonate is used in line with this guideline. The first group, the control group, will receive routine oral care in the clinic with sodium bicarbonate. Oral care will be applied 4 times a day for 14 days.

Saline Group: The second group, the experimental group, will first receive oral care routinely applied in the clinic. Then, oral care will be given in the form of 5 ml mouthwash with saline. Oral care will be applied 4 times a day for 14 days.

Black Mulberry Syrup Group: The third group, the experimental group, will first receive oral care routinely applied in the clinic. Then black mulberry syrup will be applied. Then, oral care will be given in the form of 5 ml mouthwash with black mulberry syrup. Oral care will be applied 4 times a day for 14 days.

Study summary

This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Children's International Mucositis Evaluation Scale — up to 16 days
    Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions.
  • Oral Mucositis Evaluation Index of the World Health Organization — up to 16 days
    It is scored between zero and four points. Although there is no change in the grade-0 mucosa, grade-1 painless ulcers, erythema or mild sensitivity, grade-2 painful erythema and ulcers, solid foods can be consumed. Grade-3 painful erythema, edema or ulcer can be consumed only, grade-4 ulceration, necrosis and hemorrhage are present, the patient cannot be fed, enteral or parenteral support is required.

Trial sites (1)

FacilityCityRegionStatus
Isparta City Hospital Isparta Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06525402 on ClinicalTrials.gov ↗ ← All trials in Turkey