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Completed

NCT Number: NCT05818007

Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who 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.

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Key information

Conditions

Oral Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Stomatitis Stomatognathic Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children who receive chemotherapy
  • hospitalized patient

Exclusion criteria

  • Allergy about using drugs

Treatment and study plan

Hyaluronic acid

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

Drug

sodium bicarbonate solution

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. VAS pain score

    Time frame: Day 1st

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

  10. VAS pain score

    Time frame: Day 2nd

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

  11. VAS pain score

    Time frame: Day 3rd

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

  12. VAS pain score

    Time frame: Day 4th

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

  13. VAS pain score

    Time frame: Day 5th

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

  14. VAS pain score

    Time frame: Day 6th

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

  15. VAS pain score

    Time frame: Day 7th

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

  16. VAS pain score

    Time frame: Day 11th

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

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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