Status:
UNKNOWN
Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis
Lead Sponsor:
Hams Hamed Abdelrahman
Conditions:
Oral Mucositis Due to Radiation
Eligibility:
All Genders
25+ years
Phase:
PHASE2
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 I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04308161
Start Date
November 2 2019
End Date
December 1 2020
Last Update
March 13 2020
Active Locations (1)
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1
Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
Alexandria, Egypt