Clinical trial NCT03833570: Melatonin for Prevention of Radiation Induced Oral Mucositis
Official title: The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis (Ulcerative) Due to Radiation
Keywords: Melatonin
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 given melatonin therapy 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. in addition, the total antioxidant capacity of the melatonin was evaluated at the start of the radiotherapy and six weeks later.

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 between 60-70 Gy.
* Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in severity of oral mucositis at different time points along the study
timeFrame: up to 3 and 6 weeks
measure: Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study
timeFrame: Baseline (day 0) and up to 6 weeks
Secondary outcomes:
measure: Pain and discomfort severity at different time points along the study: Numeric Rating Scale
timeFrame: up to 3 and 6 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
Study officials:
affiliation: Alexandria University
name: Hossam H Abdelaziz Elsabbagh, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Eglal M Moussa, Phd
role: STUDY_DIRECTOR
affiliation: University of Alexandria
name: Sabah AH Mahmoud, Phd
role: STUDY_DIRECTOR
affiliation: University of Alexandria
name: Rasha O Elsaka, Phd
role: STUDY_DIRECTOR
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