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

Study Overview
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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.

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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: Hyaluronic acid
* Drug: Sodium bicarbonate


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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyaluronic acid<br>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<br>* 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<br>|
| Active Comparator: sodium bicarbonate<br> | Drug: Sodium bicarbonate<br>* sodium bicarbonate solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mucositis, hyaluronic acid