Curcumin Gel On Radiation Induced Oral Mucositis

Sponsor

University of Baghdad (Other)

Overall Status

Completed

CT.gov ID

NCT05982197

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation-Induced Mucositis Head and Neck Cancer	Drug: Curcumin Gel Drug: Standard Preparation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups A) curcuma longa oral gel group B) standard treatment groupTwo groups A) curcuma longa oral gel group B) standard treatment group

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 3, 2023

Actual Primary Completion Date :

Mar 1, 2023

Actual Study Completion Date :

Jul 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Curcuma longa oral gel group	Drug: Curcumin Gel Curcuma longa oral gel for prevention radiation induced oral mucositis
Active Comparator: Standard treatment group	Drug: Standard Preparation Standard preparation for prevention radiation induced oral mucositis

Arm

Intervention/Treatment

Active Comparator: Curcuma longa oral gel group

Drug: Curcumin Gel

Curcuma longa oral gel for prevention radiation induced oral mucositis

Active Comparator: Standard treatment group

Drug: Standard Preparation

Standard preparation for prevention radiation induced oral mucositis

Outcome Measures

Primary Outcome Measures

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}

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).