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

NCT06525402 | Recruiting

• 1 other identifier: 2022/73
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis; Chemotherapy Effect

Keywords

Sodium Bicarbonate; Saline; Black Mulberry Syrup; Oral Mucositis; Chemotherapy; Children

Outcome Measures

Primary Outcomes (2)

• Children's International Mucositis Evaluation Scale

  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.

  up to 16 days

• Oral Mucositis Evaluation Index of the World Health Organization

  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.

  up to 16 days

Secondary Outcomes (1)

• Neutrophil count

  up to 16 days

Study Arms (3)

Sodium Bicarbonate Group (Usual care)

PLACEBO COMPARATOR

General routine oral 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 will receive routine oral care in the clinic with sodium bicarbonate. It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.

Other: Sodium Bicarbonate Group (Usual care)

Saline Group

EXPERIMENTAL

It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.

Other: Saline Group

Black Mulberry Syrup Group

EXPERIMENTAL

It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.

Other: Black Mulberry Syrup Group

Interventions

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.

Sodium Bicarbonate Group (Usual care)

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.

Saline Group

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.

Black Mulberry Syrup Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Isparta City Hospital

Isparta, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Selda Ateş Beşirik, Assistant Professor

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selda Ateş Beşirik, Assistant Professor

CONTACT

+905543683323; seldaates07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will be conducted as a randomized controlled trial.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: July 29, 2024
• Study Start: January 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)