NCT05818007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

April 5, 2023

Last Update Submit

April 5, 2023

Conditions

Oral Mucositis

Keywords

mucositishyaluronic acid

Outcome Measures

Primary Outcomes (16)

  • 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.

    day 1st

  • 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.

    day 2nd

  • 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.

    day 3rd

  • 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.

    day 4th

  • 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.

    day 5th

  • 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.

    day 6th

  • 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.

    day 7th

  • 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.

    day 11th

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 1st

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 2nd

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 3rd

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 4th

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 5th

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 6th

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 7th

  • VAS pain score

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

    Day 11th

Study Arms (2)

hyaluronic acid

EXPERIMENTAL

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

sodium bicarbonate

ACTIVE COMPARATOR
Drug: Sodium bicarbonate

Interventions

Hyaluronic acidDRUG

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

hyaluronic acid
Sodium bicarbonateDRUG

sodium bicarbonate solution

sodium bicarbonate

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children who receive chemotherapy
  • hospitalized patient

You may not qualify if:

  • \- Allergy about using drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StomatitisMucositis

Interventions

Hyaluronic AcidSodium Bicarbonate

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesBicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

April 1, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

TU(1)