Curcumin Gel On Radiation Induced Oral Mucositis

August 4, 2023 updated by: sarah adnan abdul-jabbar, University of Baghdad

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq, 10053
        • Nuclear medicine and radiation therapy hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
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}
Assessment every week starting from first visit of radiation unit it completion (average of 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

July 2, 2023

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 705722

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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