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

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818007
• Other study ID #: YYU-06/03.07.2019
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• children who receive chemotherapy

• hospitalized patient

Exclusion Criteria:

• Allergy about using drugs

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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
• Sodium bicarbonate
sodium bicarbonate solution

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 1st
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 2nd
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 3rd
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 4th
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 5th
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 6th
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 7th
Primary	VAS pain score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.	Day 11th