Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

Study Overview
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Brief Summary
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The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis

Detailed Description
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The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment. All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.

Official Title
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The Effectiveness of Topical Oral Vitamin D Gel in Prevention of Radiation-induced Oral Mucositis

Conditions
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Oral Mucositis Due to Radiation

Intervention / Treatment
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* Drug: vitamin D oral gel
* Drug: Miconazole Topical Gel
* Drug: BBC oral spray
* Drug: Oracure gel
* Other: Alkamisr sachets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy. Patients whose radiotherapy treatment planned dose is 50 Gy or above. Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy. Exclusion Criteria: Patients under Anticoagulants such as warfarin, heparin, or aspirin. Patients whose radiotherapy treatment planned dose is lower than 50 Gy. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure. Hyper-calcemic patients. Smokers.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D oral gel<br>Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks. Topical oral Vitamin D gel is prepared with the aid of pharmaceutics department, faculty of pharmacy, Alexandria University. It is prepared by using Cholecalciferol 2ml ampoule (200.000 I.U.) within topical oral gel formulation. | Drug: vitamin D oral gel<br>* vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis<br>|
| Active Comparator: conventional therapy<br>Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Dose: Three times a day for six weeks | Drug: Miconazole Topical Gel<br>* topical anti fungal agent<br>Drug: BBC oral spray<br>* Topical anesthetics and anti-inflammatory agent<br>Drug: Oracure gel<br>* Topical analgesic gel<br>Other: Alkamisr sachets<br>* Sodium bicarbonate mouthwash<br>|
| Experimental: combination therapy<br>Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment Symptomatic treatment which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Symptomatic treatment dose: Three times a day for six weeks | Drug: vitamin D oral gel<br>* vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis<br>Drug: Miconazole Topical Gel<br>* topical anti fungal agent<br>Drug: BBC oral spray<br>* Topical anesthetics and anti-inflammatory agent<br>Drug: Oracure gel<br>* Topical analgesic gel<br>Other: Alkamisr sachets<br>* Sodium bicarbonate mouthwash<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of oral mucositis at different time points along the study | Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session. | up to 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session. | up to 3 and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D topical oral gel