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Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Hyaluronic acid
Sodium bicarbonate
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Mucositis focused on measuring mucositis, hyaluronic acid

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: children who receive chemotherapy hospitalized patient Exclusion Criteria: - Allergy about using drugs

Sites / Locations

  • Yuzuncu Yil University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hyaluronic acid

sodium bicarbonate

Arm Description

The hyaluronic acid is a natural polysaccharide composed of D-glucuronic acid and N-acetyl-D-glucosamine and is synthesized as a linear polymer. The majority of the cells have a capacity to synthesize HA at a varying extent in the cell cycle.

Outcomes

Primary Outcome Measures

World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
World Health Organization Common Toxicity Criteria Scale
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2023
Last Updated
April 5, 2023
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT05818007
Brief Title
Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy
Official Title
The Effects of Hyaluronic Acid Gel on Oral Mucositis in Children Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Oral mucositis (OM) is a common side effect of systemic chemotherapy (CT) in cancer patients. The aim of this study was to investigate the effect of hyaluronic acid (HA) gel on OM in children receiving CT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
mucositis, hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyaluronic acid
Arm Type
Experimental
Arm Description
The hyaluronic acid is a natural polysaccharide composed of D-glucuronic acid and N-acetyl-D-glucosamine and is synthesized as a linear polymer. The majority of the cells have a capacity to synthesize HA at a varying extent in the cell cycle.
Arm Title
sodium bicarbonate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Intervention Description
The main function of HA appears to be in tissue healing, by activating and modulating inflammatory responses, stimulating cellular proliferation, migration, and angiogenesis, inducing basal keratinocyte proliferation and re-epithelization by reducing collagen deposition and scarring
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
sodium bicarbonate solution
Primary Outcome Measure Information:
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 1st
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 2nd
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 3rd
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 4th
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 5th
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 6th
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 7th
Title
World Health Organization Common Toxicity Criteria Scale
Description
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
Time Frame
day 11th
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 1st
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 2nd
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 3rd
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 4th
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 5th
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 6th
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 7th
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
Day 11th

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children who receive chemotherapy hospitalized patient Exclusion Criteria: - Allergy about using drugs
Facility Information:
Facility Name
Yuzuncu Yil University
City
Van
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

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