Oral MucositisPhase 4NCT05818007
Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy
A Phase 4 study testing Hyaluronic acid and Sodium bicarbonate in people with Oral Mucositis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Hyaluronic acid and Sodium bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children who receive chemotherapy
- hospitalized patient
Who cannot join
- Allergy about using drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Hyaluronic Acid Gel on Oral Mucositis in Children Receiving Chemotherapy
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.
- Conditions
- Oral Mucositis
- Being tested
- Hyaluronic acid, Sodium bicarbonate
- Keywords
- mucositis, hyaluronic acid
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Sodium bicarbonateDrug
sodium bicarbonate solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hyaluronic acid |
| sodium bicarbonate | Active comparator | Not described Receives: Drug: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 11th
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 1st
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 2nd
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 3rd
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 4th
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 5th
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 6th
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 7th
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: Day 11th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818007
- Sponsor's protocol ID
- YYU-06/03.07.2019
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyaluronic Acid Gel on Oral Mucositis in Children Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05818007
- Acronym / sponsor ID
- YYU-06/03.07.2019
- Conditions
- Oral Mucositis
- Keywords
- mucositis, hyaluronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid | Experimental | Drug: Hyaluronic acidThe 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. |
| sodium bicarbonate | Active comparator | Drug: Sodium bicarbonate |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children who receive chemotherapy
- hospitalized patient
Key exclusion criteria (1 listed)
- Allergy about using drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acidThe 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 | Drug | hyaluronic acid |
| Sodium bicarbonatesodium bicarbonate solution | Drug | sodium bicarbonate |
Primary outcome
World Health Organization Common Toxicity Criteria Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1st
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: Day 2nd
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: Day 3rd
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: Day 4th
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: Day 5th
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: Day 6th
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: Day 7th
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: Day 11th
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid and Sodium bicarbonate in people with Oral Mucositis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Common Toxicity Criteria Scale (time frame: day 1st). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.