Oral Mucositis (Ulcerative) Due to Radiation Clinical Trial
Official title:
Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis: a Randomised Clinical Control Trial
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Salma Hesham Elhoufi | Cairo | Select |
Lead Sponsor | Collaborator |
---|---|
Salma Hesham Elhoufi |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Oral Radiation mucositis | 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 ) | Every other week (at baseline, 2 weeks, 4 weeks and 6 at the end of the treatment) | |
Primary | Grade of oral radiation mucositis | 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 ) | Every other week (at baseline, 2 weeks, 4 weeks and 6 weeks at the end of the treatment) | |
Secondary | Post operative pain assessment using Numeric Pain Rating Scale | 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") | Patients scores will be recorded after starting radiotherapy every other week (at baseline, 2 weeks, 4 weeks and 6 weeks at the end of the treatment) | |
Secondary | Total antioxidant capacity | 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 | 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. |
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