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

NCT05322421 | Completed DMC

• 1 other identifier: FDASU-REC 964123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

radiation; mucositis; oral; stomatitis; olive oil

Outcome Measures

Primary Outcomes (2)

• 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 ( 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 ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)

Secondary Outcomes (2)

• 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)

• 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.

Study Arms (2)

Olive Oil

EXPERIMENTAL

Will include10 patients receiving topical olive oil application, twice daily

Other: Topical Olive Oil

Sodium Bicarbonate

ACTIVE COMPARATOR

Will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily

Other: Sodium bicarbonate 5% solution

Interventions

Topical Olive Oil OTHER

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

Olive Oil

Sodium bicarbonate 5% solution OTHER

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

Sodium Bicarbonate

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salma Hesham Elhoufi: lead

Study Sites (1)

Salma Hesham Elhoufi

Cairo, Select, 11571, Egypt

Location

MeSH Terms

Conditions

Stomatitis; Ulcer; Mucositis

Interventions

Olive Oil; Sodium Bicarbonate; Solutions

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations

Study Officials

• Suzan S Ibrahim, Professor

  Ain Shams University

  STUDY DIRECTOR

• Radwa Ragheb, Lecturer

  Ain Shams University

  STUDY DIRECTOR

• Salma H Elhoufi

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investiagtor

Model Details: This study is designed as a parallel randomized control clinical trial

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: April 11, 2022
• Study Start: January 10, 2022
• Primary Completion: September 10, 2022
• Study Completion: December 15, 2022
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)