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Clinical Trial Summary

This research aims to investigate the effectiveness of topical olive oil application both clinically and biochemically as a suitable affordable treatment modality for prevention and management of radiation oral mucositis and its associated pain for head and neck cancer patients receiving radiotherapy.


Clinical Trial Description

Twenty adult patients seeking radiotherapy treatment for head and neck cancer are to be selected. Patients meeting the eligibility criteria are to be equally and randomly allocated in 2 different groups. Group 1 will include10 patients receiving topical olive oil application, twice daily (Experimental arm). Group 2 will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily (Control arm). Both intervention and control groups will start the application of the agents two days before the induction of radiotherapy. Evaluation will be done using World Health Organization (WHO) scale for oral mucositis to record the extent and severity of oral mucositis. Clinical evaluation will be performed after starting radiotherapy every other week (at baseline, after 2 weeks, after 4 weeks and after 6 weeks at the end of the treatment). Pain and discomfort will be evaluated using Numeric Rating Scale (NRS). Patients scores will be recorded at similar intervals. Total Antioxidant Capacity "TAC" will be used to study the biochemical effect of topical olive oil application by evaluating the oxidative stress in the saliva. Saliva samples will be collected from all patients of both groups prior to the beginning of radiotherapy, and a second sample will be collected after six weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05322421
Study type Interventional
Source Ain Shams University
Contact Salma H Elhoufi
Phone 00201018222825
Email salooma92@gmail.com
Status Recruiting
Phase N/A
Start date January 10, 2022
Completion date September 2022

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Active, not recruiting NCT03387774 - Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients Phase 3
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Active, not recruiting NCT03972527 - Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients N/A
Recruiting NCT06354712 - Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients. Phase 2