NCT05322421

Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis

Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis: a Randomised Clinical Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Salma Hesham Elhoufi · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. Pain and discomfort will be evaluated using Numeric Rating Scale (NRS). Clinical evaluation using both scales will be performed after starting radiotherapy every other week ( after 2 weeks, after 4 weeks and after 6 weeks at the end of the treatment). 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.

Conditions

• Radiation Mucositis
• Oral Mucositis (Ulcerative) Due to Radiation
• Radiation-Induced Mucositis

Interventions

Type	Name	Description
OTHER	Topical Olive Oil	Olive oil will be placed in 200 ml opaque glass containers. For each application, a new stick with a sponge will be submerged into one of the agents to absorb then coat the tongue, buccal mucosa, lips, and hard palate. Patients will be instructed to refrain form eating for 1 hour after the application
OTHER	Sodium bicarbonate 5% solution	Sodium bicarbonate 5% solution will be placed in 200 ml opaque glass containers. For each application, a new stick with a sponge will be submerged into one of the agents to absorb then coat the tongue, buccal mucosa, lips, and hard palate. Patients will be instructed to refrain form eating for 1 hour after the application

Timeline

• Start date: 2022-01-10
• Primary completion: 2022-09-10
• Completion: 2022-12-15
• First posted: 2022-04-11
• Last updated: 2024-08-02

Locations

1 site across 1 country: Egypt