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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Mucositis (Ulcerative) Due to Radiation; Radiation-Induced Mucositis; Radiation Mucositis
• Intervention / Treatment: Other: Topical Olive Oil; Other: Sodium bicarbonate 5% solution

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. 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salma H Elhoufi; Phone Number: 00201018222825; Email: salooma92@gmail.com

Study Locations

• Egypt
  • Select
    • Cairo, Select, Egypt, 11571
      • Recruiting
      • Salma Hesham Elhoufi
      • Contact: Salma H Elhoufi; Email: salooma92@gmail.com
      • Contact: Radwa Ragheb, lecturer; Email: radwa.ragheb@dent.asu.edu.eg
      • Principal Investigator: Salma H Elhoufi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olive Oil; Will include10 patients receiving topical olive oil application, twice daily	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
Active Comparator: Sodium Bicarbonate; Will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.

Collaborators and Investigators

• Sponsor: Salma Hesham Elhoufi
• Investigators: Study Director: Suzan S Ibrahim, Professor, Ain Shams University; Study Director: Radwa Ragheb, Lecturer, Ain Shams University; Principal Investigator: Salma H Elhoufi, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: radiation; oral; mucositis; olive oil; stomatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: FDASU-REC 964123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No