Curcumin Gel On Radiation Induced Oral Mucositis

NCT05982197 | Completed

• 1 other identifier: 705722
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-Induced Mucositis; Head and Neck Cancer

Keywords

Radiation induced oral mucositis; Head and neck cancer; Curcuma longa; EGF; IL8

Outcome Measures

Primary Outcomes (2)

• Onset of radiation induced mucositis

  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

  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)

Study Arms (2)

Curcuma longa oral gel group

ACTIVE COMPARATOR

Drug: Curcumin Gel

Standard treatment group

ACTIVE COMPARATOR

Drug: Standard Preparation

Interventions

Curcumin Gel DRUG

Curcuma longa oral gel for prevention radiation induced oral mucositis

Curcuma longa oral gel group

Standard Preparation DRUG

Standard preparation for prevention radiation induced oral mucositis

Standard treatment group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• patient with hodgkin lymphoma.
• Any allergy to curcumin or other condiments.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Nuclear medicine and radiation therapy hospital

Baghdad, 10053, Iraq

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Two groups A) curcuma longa oral gel group B) standard treatment group

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: August 8, 2023
• Study Start: January 3, 2023
• Primary Completion: March 1, 2023
• Study Completion: July 2, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

IR (1)