Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis
Oral Mucositis Due to Radiation
About this trial
This is an interventional prevention trial for Oral Mucositis Due to Radiation focused on measuring vitamin D topical oral gel
Eligibility Criteria
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.
Sites / Locations
- Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
vitamin D oral gel
conventional therapy
combination therapy
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.
Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Dose: Three times a day for six weeks
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