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

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Completed

CT.gov ID

NCT05818007

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis	Drug: Hyaluronic acid Drug: Sodium bicarbonate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Hyaluronic Acid Gel on Oral Mucositis in Children Receiving Chemotherapy

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Mar 1, 2023

Actual Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hyaluronic acid 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.	Drug: Hyaluronic acid 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
Active Comparator: sodium bicarbonate	Drug: Sodium bicarbonate sodium bicarbonate solution

Arm

Intervention/Treatment

Experimental: hyaluronic acid

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.

Drug: Hyaluronic acid

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

Active Comparator: sodium bicarbonate

Drug: Sodium bicarbonate

sodium bicarbonate solution

Outcome Measures

Primary Outcome Measures

World Health Organization Common Toxicity Criteria Scale [day 1st]
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 [day 2nd]
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 [day 3rd]
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 [day 4th]
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 [day 5th]
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 [day 6th]
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 [day 7th]
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 [day 11th]
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 [Day 1st]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [Day 2nd]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [Day 3rd]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [Day 4th]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [Day 5th]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [Day 6th]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [Day 7th]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score [Day 11th]
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children who receive chemotherapy
hospitalized patient

Exclusion Criteria:

Allergy about using drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yuzuncu Yil University	Van		Turkey	65080

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Serap Keskin Tunc, associate professor, Yuzuncu Yıl University

ClinicalTrials.gov Identifier:

NCT05818007

Other Study ID Numbers:

YYU-06/03.07.2019

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Serap Keskin Tunc, associate professor, Yuzuncu Yıl University

mucositis

hyaluronic acid

Additional relevant MeSH terms:

Mucositis

Stomatitis

Hyaluronic Acid

Study Results

No Results Posted as of Apr 18, 2023