Status:
COMPLETED
Melatonin for Prevention of Radiation Induced Oral Mucositis
Lead Sponsor:
Hams Hamed Abdelrahman
Collaborating Sponsors:
Alexandria University
Conditions:
Oral Mucositis (Ulcerative) Due to Radiation
Eligibility:
All Genders
25+ years
Phase:
PHASE2
Brief Summary
The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.
Detailed Description
The study was designed as randomized, controlled, clinical trial. patients who were undergoing chemoradiation were divided into two groups: Group I: was given conventional treatment. Group II: was giv...
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 between 60-70 Gy.
- Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy.
Exclusion
- Patients under Anticoagulants such as warfarin, heparin, or aspirin.
- Patients under Fluvoxamine (Luvox) and Nifedipine medications.
- Patients whose radiotherapy treatment planned dose is lower than 60 Gy.
- Pregnant and lactating women.
- 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.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03833570
Start Date
January 12 2018
End Date
December 1 2018
Last Update
June 17 2019
Active Locations (1)
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1
Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
Alexandria, Egypt