Curcumin Gel On Radiation Induced Oral Mucositis

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Radiation-Induced Mucositis
• Interventions: Drug: Standard Preparation; Drug: Curcumin Gel

• Registration Number: NCT05982197
• Lead Sponsor: University of Baghdad

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Primary Completion: 2023-03-01
• Study First Submitted: 2023-06-22
• Study Completion: 2023-07-02
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment group	Standard Preparation	-
Curcuma longa oral gel group	Curcumin Gel	-

Primary Outcome Measures

Name	Time	Method
Onset of radiation induced mucositis	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
Change in severity of radiation induced mucositis	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}

Trial Locations

Locations (1)

Nuclear medicine and radiation therapy hospital; 🇮🇶 Baghdad, Iraq