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NCT Number: NCT05322421

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

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.

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Key information

Conditions

Radiation Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Oral Mucositis (Ulcerative) Due to Radiation Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation-Induced Mucositis Stomatitis Stomatognathic Diseases Ulcer

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salma Hesham Elhoufi

Cairo, Select, 11571, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Incidence of Oral Radiation mucositis

    Time frame: Every other week ( 2 weeks, 4 weeks and 6 at the end of the treatment)

    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 )

  2. Grade of oral radiation mucositis

    Time frame: Every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)

    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 )

Secondary outcomes

  1. Post operative pain assessment using Numeric Pain Rating Scale

    Time frame: Patients scores will be recorded after starting radiotherapy every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)

    To evaluate patient's perception of postoperative pain during the treatment time using the NRS (Numeric Pain Rating Scale). The NRS is an 11-point numeric scale that ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  2. Total antioxidant capacity

    Time frame: 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.

    To evaluate the biochemical effect of topical olive oil application using the Total Antioxidant Capacity (TAC) test in the saliva of patients with radiation oral mucositis

Sponsors and collaborators

Lead sponsor

Salma Hesham Elhoufi

Other

Registry information

Official study title

Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis: a Randomised Clinical Control Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2022
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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