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Completed

NCT Number: NCT05982197

Curcumin Gel On Radiation Induced Oral Mucositis

The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.

Researchers will compare between curcumin group and standard treatment group.

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Key information

Conditions

Radiation-Induced Mucositis Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuclear medicine and radiation therapy hospital

Baghdad, 10053, Iraq

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients above 16 years having histopathologically confirmed cancer in head and neck region who planned to have radiation with head and neck mask.
  • Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5 days/week).

Exclusion criteria

  • patient with hodgkin lymphoma.
  • Any allergy to curcumin or other condiments.

Treatment and study plan

Curcumin Gel

Drug

Curcuma longa oral gel for prevention radiation induced oral mucositis

Standard Preparation

Drug

Standard preparation for prevention radiation induced oral mucositis

Primary outcomes

  1. Onset of radiation induced mucositis

    Time frame: Assessment every week starting from first visit until the onset of mucositis (up to 2 months)

    Onset (at which week) of radiation induced mucositis in relation to EGF and IL8

  2. Change in severity of radiation induced mucositis

    Time frame: Assessment every week starting from first visit of radiation unit it completion (average of 2 months)

    Change in severity (degree of illness) of radiation induced mucositis in relation to EGF & IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Aug 8, 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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