Clinical trial NCT05322421: Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis
Official title: Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis: a Randomised Clinical Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Mucositis
Oral Mucositis (Ulcerative) Due to Radiation
Radiation-Induced Mucositis
Keywords: radiation
mucositis
oral
stomatitis
olive oil
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a parallel randomized control clinical trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Oral Radiation mucositis
timeFrame: Every other week ( 2 weeks, 4 weeks and 6 at the end of the treatment)
measure: Grade of oral radiation mucositis
timeFrame: Every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Secondary outcomes:
measure: Post operative pain assessment using Numeric Pain Rating Scale
timeFrame: Patients scores will be recorded after starting radiotherapy every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
measure: Total antioxidant capacity
timeFrame: 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.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Salma Hesham Elhoufi
state: Select
Study officials:
affiliation: Ain Shams University
name: Suzan S Ibrahim, Professor
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Radwa Ragheb, Lecturer
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Salma H Elhoufi
role: PRINCIPAL_INVESTIGATOR
References: