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

NCT ID: NCT05322421

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-12-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Olive Oil

Will include10 patients receiving topical olive oil application, twice daily

Group Type: EXPERIMENTAL

Topical Olive Oil

Intervention Type: 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

Sodium Bicarbonate

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

Group Type: ACTIVE_COMPARATOR

Sodium bicarbonate 5% solution

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salma Hesham Elhoufi

OTHER

Sponsor Role: lead

Responsible Party

Salma Hesham Elhoufi

Principal Investiagtor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suzan S Ibrahim, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Radwa Ragheb, Lecturer

Role: STUDY_DIRECTOR

Ain Shams University

Salma H Elhoufi

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Salma Hesham Elhoufi

Cairo, Select, Egypt

Countries

Egypt

Other Identifiers

FDASU-REC 964123

Identifier Type: -

Identifier Source: org_study_id