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

Salma Hesham Elhoufi

Status: Enrolling

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

Treatments: Other: Sodium bicarbonate 5% solution; Other: Topical Olive Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05322421

FDASU-REC 964123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Olive Oil

Experimental group

Description:

Will include10 patients receiving topical olive oil application, twice daily

Treatment:

Other: Topical Olive Oil

Sodium Bicarbonate

Active Comparator group

Description:

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

Treatment:

Other: Sodium bicarbonate 5% solution