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

S

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

Trial contacts and locations

1

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Central trial contact

Salma H Elhoufi

Data sourced from clinicaltrials.gov

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