Clinical trial NCT06525402: Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Mucositis
Chemotherapy Effect
Keywords: Sodium Bicarbonate
Saline
Black Mulberry Syrup
Oral Mucositis
Chemotherapy
Children
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted as a randomized controlled trial.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Oral mucositis, also known as stomatitis, is the most common complication of cancer treatment. Mucositis affects the patient's nutrition, daily functions, and quality of life, may compromise the ability to tolerate scheduled therapy. For this reason, the children to be included in the study will be randomly divided into three groups. Sodium bicarbonate, which is the routine care in the clinic, will be administered to the control group, and to the intervention groups, saline in addition to the routine care and black mulberry syrup will be applied in addition to the routine care. Data will be collected according to Patient Information Form, International Child Mucositis Assessment Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts. Oral care will be applied to the groups 4 times a day for 14 days. The International Child Mucositis Rating Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts will be evaluated by the researchers on the 1st, 2nd, 4th, 8th and 16th days.

Eligibility 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

Primary outcomes:
measure: Children's International Mucositis Evaluation Scale
timeFrame: up to 16 days
measure: Oral Mucositis Evaluation Index of the World Health Organization
timeFrame: up to 16 days
Secondary outcomes:
measure: Neutrophil count
timeFrame: up to 16 days
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Isparta City Hospital
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Selda Ateş Beşirik, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References: