- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05982197
Curcumin Gel On Radiation Induced Oral Mucositis
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Baghdad, Iraq, 10053
- Nuclear medicine and radiation therapy hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
Curcuma longa oral gel for prevention radiation induced oral mucositis
|
Active Comparator: Standard treatment group
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Head and Neck Neoplasms
- Mucositis
- Stomatitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 705722
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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