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NCT05982197 Clinical Trial

Curcumin Gel On Radiation Induced Oral Mucositis

Head and Neck Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05982197
Other study ID # 705722
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date July 2, 2023

Study information
Verified date August 2023
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Curcumin Gel
Curcuma longa oral gel for prevention radiation induced oral mucositis
• Standard Preparation
Standard preparation for prevention radiation induced oral mucositis

Locations
Country Name City State
Iraq Nuclear medicine and radiation therapy hospital Baghdad

Sponsors (1)
Lead Sponsor Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome
Type Measure Description Time frame Safety issue
Primary Onset of radiation induced mucositis Onset (at which week) of radiation induced mucositis in relation to EGF and IL8 Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
Primary Change in severity of radiation induced mucositis 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} Assessment every week starting from first visit of radiation unit it completion (average of 2 months)
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