Oral Mucositis (Ulcerative) Due to Radiation
Conditions
Keywords
Melatonin
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.
Interventions
DRUGOracure gel
Topical analgesic gel
DIETARY_SUPPLEMENTRapid Release Capsules Melatonin, 10 mg
Melatonin is a dietary supplement which is naturally produced in the body and closely involved in the natural sleep cycle. recently topical and systemic melatonin supplements. have been proposed as a new therapeutic modality for oral mucositis due to its anti-cancer, anti-inflammatory, and anti-oxidant effects.
DRUGMiconaz oral gel
Antifungal agent
DRUGBBC oral spray
Topical anesthetics and anti-inflammatory agent
OTHERAlkamisr sachets
Sodium bicarbonate mouthwash
Sponsors
Alexandria University
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in severity of oral mucositis at different time points along the study | up to 3 and 6 weeks | Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session. This scale combines both subjective and objective measures of oral mucositis. World Health Organization (WHO) scale for oral mucositis: * Grade 0 = No oral mucositis * Grade 1 = Erythema and Soreness * Grade 2 = Ulcers, able to eat solids * Grade 3 = Ulcers, requires liquid diet (due to mucositis) * Grade 4 = Ulcers, alimentation not possible (due to mucositis) |
| Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study | Baseline (day 0) and up to 6 weeks | TAC is an index that measures total capacity of antioxidants in biological fluids using Colorimetric Method. it can evaluate the antioxidant response against the free radicals produced by radiotherapy. Normal reference values for TAC in saliva: 0.3-1 mM/L Higher values than normal range indicate higher level of TAC Changes in the total antioxidant capacity were evaluated at the first day of radiotherapy session (baseline) and six weeks later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | up to 3 and 6 weeks | Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session. The NRS was calibrated from 0 to 10 with ranges tagged as; * No pain (NRS 0) * Mild pain (NRS 1-3) * Moderate pain (NRS 4-7) * Unbearable pain (NRS 8-10) |
Countries
Egypt
Outcome results
None listed