Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

Phase 2

• Conditions: Oral Mucositis Due to Radiation
• Interventions: Drug: vitamin D oral gel; Drug: BBC oral spray; Drug: Miconazole Topical Gel; Drug: Oracure gel; Other: Alkamisr sachets

• Registration Number: NCT04308161
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-11-02
• Status Verified: 2020-03
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13
• Primary Completion: 2020-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional therapy	BBC oral spray	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
conventional therapy	Oracure gel	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
conventional therapy	Alkamisr sachets	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
combination therapy	Miconazole Topical Gel	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
combination therapy	Alkamisr sachets	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
conventional therapy	Miconazole Topical Gel	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
combination therapy	vitamin D oral gel	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
combination therapy	BBC oral spray	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
combination therapy	Oracure gel	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
vitamin D oral gel	vitamin D oral gel	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.

Primary Outcome Measures

Name	Time	Method
Changes in severity of oral mucositis at different time points along the study	up to 3 and 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Pain and discomfort severity at different time points along the study: Numeric Rating Scale	up to 3 and 6 weeks	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.

Trial Locations

Locations (1)

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt