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

Not Applicable

Completed

• Conditions: Oral Mucositis (Ulcerative) Due to Radiation; Radiation-Induced Mucositis; Radiation Mucositis
• Interventions: Other: Topical Olive Oil; Other: Sodium bicarbonate 5% solution

• Registration Number: NCT05322421
• Lead Sponsor: Salma Hesham Elhoufi

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-01
• Study Start: 2022-01-10
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-11
• Primary Completion: 2022-09-10
• Study Completion: 2022-12-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who are aged above 25 years up to 65 years.
• Both genders are eligible.
• Patients with head and neck cancer who are planned to receive radiotherapy either as postoperative (adjuvant after surgery) or definitive therapy.
• Patients planned to receive radiotherapy treatment with a dose of 60-70 Gy.

Exclusion Criteria

• Patients with known sensitivity to olive oil and/or any of its products
• Patients with gingival or oral ulceration or mucositis
• Smokers
• Vulnerable patients (pregnant women, neonates, children, prisoners, persons with physical handicaps or mental disabilities)
• Pregnant and lactating women.
• Patients with any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
• Patients suffering from any physical or mental disabilities that would interfere with or be affected by the study procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olive Oil	Topical Olive Oil	Will include10 patients receiving topical olive oil application, twice daily
Sodium Bicarbonate	Sodium bicarbonate 5% solution	Will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily

Primary Outcome Measures

Name	Time	Method
Incidence of Oral Radiation mucositis	Every other week ( 2 weeks, 4 weeks and 6 at the end of the treatment)	Number of participants who develop Radiation mucositis according to the WHO Scale. (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )
Grade of oral radiation mucositis	Every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)	Clinical evaluation using the WHO scale will be performed to record the changes in the oral cavity after starting radiotherapy, (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )

Secondary Outcome Measures

Name	Time	Method
Total antioxidant capacity	Salivary samples will be collected at baseline before the induction of radiotherapy and at 6 weeks at the end of the treatment for TAC analysis.	To evaluate the biochemical effect of topical olive oil application using the Total Antioxidant Capacity (TAC) test in the saliva of patients with radiation oral mucositis
Post operative pain assessment using Numeric Pain Rating Scale	Patients scores will be recorded after starting radiotherapy every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)	To evaluate patient's perception of postoperative pain during the treatment time using the NRS (Numeric Pain Rating Scale). The NRS is an 11-point numeric scale that ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Trial Locations

Locations (1)

Salma Hesham Elhoufi; 🇪🇬 Cairo, Select, Egypt