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

Oral Mucositis (Ulcerative) Due to Radiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322421
• Other study ID #: FDASU-REC 964123
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: September 2022

Study information

• Verified date: April 2022
• Source: Ain Shams University
• Contact: Salma H Elhoufi
• Phone: 00201018222825
• Email: salooma92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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
• Patients taking of any antiviral or antifungal therapy and/or any other agents for oral mucositis before the beginning of the study for 3 months.
• 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.

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Salma Hesham Elhoufi	Cairo	Select

Sponsors (1)

Lead Sponsor	Collaborator
Salma Hesham Elhoufi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Oral Radiation mucositis	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 )	Every other week (at baseline, 2 weeks, 4 weeks and 6 at the end of the treatment)
Primary	Grade of oral radiation mucositis	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 )	Every other week (at baseline, 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Secondary	Post operative pain assessment using Numeric Pain Rating Scale	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")	Patients scores will be recorded after starting radiotherapy every other week (at baseline, 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Secondary	Total antioxidant capacity	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	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.