Back to resultsCurcumin Gel On Radiation Induced Oral Mucositis
Primary Purpose
Radiation-Induced Mucositis, Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Curcumin Gel
Standard Preparation
Sponsored by
About this trial
This is an interventional prevention trial for Radiation-Induced Mucositis focused on measuring Radiation induced oral mucositis, Head and neck cancer, Curcuma longa, EGF, IL8
Eligibility Criteria
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.
Sites / Locations
- Nuclear medicine and radiation therapy hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Curcuma longa oral gel group
Standard treatment group
Arm Description
Outcomes
Primary Outcome Measures
Onset of radiation induced mucositis
Onset (at which week) of radiation induced mucositis in relation to EGF and IL8
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}
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05982197
Brief Title
Curcumin Gel On Radiation Induced Oral Mucositis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
July 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-Induced Mucositis, Head and Neck Cancer
Keywords
Radiation induced oral mucositis, Head and neck cancer, Curcuma longa, EGF, IL8
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups A) curcuma longa oral gel group B) standard treatment group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcuma longa oral gel group
Arm Type
Active Comparator
Arm Title
Standard treatment group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Curcumin Gel
Intervention Description
Curcuma longa oral gel for prevention radiation induced oral mucositis
Intervention Type
Drug
Intervention Name(s)
Standard Preparation
Intervention Description
Standard preparation for prevention radiation induced oral mucositis
Primary Outcome Measure Information:
Title
Onset of radiation induced mucositis
Description
Onset (at which week) of radiation induced mucositis in relation to EGF and IL8
Time Frame
Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
Title
Change in severity of radiation induced mucositis
Description
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}
Time Frame
Assessment every week starting from first visit of radiation unit it completion (average of 2 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nuclear medicine and radiation therapy hospital
City
Baghdad
ZIP/Postal Code
10053
Country
Iraq
12. IPD Sharing Statement
Learn more about this trial
Curcumin Gel On Radiation Induced Oral Mucositis
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