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

NCT ID: NCT05818007

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DRUG

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

sodium bicarbonate

Group Type ACTIVE_COMPARATOR

Sodium bicarbonate

Intervention Type DRUG

sodium bicarbonate solution

Interventions

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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

Intervention Type DRUG

Sodium bicarbonate

sodium bicarbonate solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* children who receive chemotherapy
* hospitalized patient

Exclusion Criteria

\- Allergy about using drugs
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Serap Keskin Tunc

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yuzuncu Yil University

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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YYU-06/03.07.2019

Identifier Type: -

Identifier Source: org_study_id

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