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NCT Number: NCT06525402

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isparta City Hospital

Isparta, Turkey (Türkiye)

Location status: Recruiting

Location contact

Selda Ateş Beşirik, Assistant Prof.

CONTACT

[email protected]

+905543683323

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Bicarbonate Group (Usual care)

Other

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

Other

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

Other

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.

Primary outcomes

  1. Children's International Mucositis Evaluation Scale

    Time frame: 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.

  2. Oral Mucositis Evaluation Index of the World Health Organization

    Time frame: 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.

Secondary outcomes

  1. Neutrophil count

    Time frame: up to 16 days

    The neutrophil count will be evaluated. Numbers will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Selda Ateş Beşirik, Assistant Professor

CONTACT

[email protected]

+905543683323

Sponsors and collaborators

Lead sponsor

Burdur Mehmet Akif Ersoy University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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