Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

Hams Hamed Abdelrahman

Status and phase: Unknown; Phase 2

Conditions: Oral Mucositis Due to Radiation

Treatments: Drug: Oracure gel; Other: Alkamisr sachets; Drug: Miconazole Topical Gel; Drug: vitamin D oral gel; Drug: BBC oral spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04308161

IRB NO: 00010556-IORG 0008839

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

vitamin D oral gel

Experimental group

Description:

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.

Treatment:

Drug: vitamin D oral gel

conventional therapy

Active Comparator group

Description:

Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks

Treatment:

Drug: Miconazole Topical Gel

Other: Alkamisr sachets

Drug: BBC oral spray

Drug: Oracure gel

combination therapy

Experimental group

Description:

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

Treatment:

Drug: Miconazole Topical Gel

Drug: vitamin D oral gel

Other: Alkamisr sachets

Drug: BBC oral spray

Drug: Oracure gel