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Efficacy of Melatonin in prevention of radiation-induced oral mucositis: A randomized clinical trial.

Oral diseases
April 1, 2020
Hossam H Elsabagh et al. (5 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate whether melatonin could effectively prevent radiation-induced oral mucositis in head and neck cancer patients undergoing radiotherapy.

Results Summary

Melatonin administration (20 mg) alongside conventional treatment reduced severe oral mucositis incidence (5% vs. 30% in controls), decreased pain scores, and preserved salivary antioxidant capacity compared to controls.

Population

Forty head and neck cancer patients undergoing radiotherapy at a university hospital in Egypt.

Effective Dosage

20 mg melatonin (frequency not specified).

Duration

Six weeks (assessed at three and six weeks).

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin (20 mg) along with conventional treatment
decrease
severe oral mucositis development
head and neck cancer patients undergoing radiotherapy
-
reduced severe oral mucositis development
#1
melatonin (20 mg) along with conventional treatment
decrease
pain scores
head and neck cancer patients undergoing radiotherapy
-
aided in decreasing pain
#2
melatonin (20 mg) along with conventional treatment
decrease
total antioxidant capacity (TAC)
head and neck cancer patients undergoing radiotherapy
-
hindering the reduction of TAC
#3
conventional treatment (control group)
increase
oral mucositis severity
head and neck cancer patients undergoing radiotherapy
30%
more severity reported
#4
melatonin (20 mg) along with conventional treatment
decrease
oral mucositis severity
head and neck cancer patients undergoing radiotherapy
5%
less severity reported
#5
radiotherapy
decrease
total antioxidant capacity (TAC)
head and neck cancer patients
-
resulting in reduction of TAC
#6
Abstract

OBJECTIVES: Evaluating the effectiveness of melatonin in prevention of radiation-induced oral mucositis. MATERIAL AND METHODS: A randomized controlled clinical study was conducted on forty head and neck cancer (HNC) patients undergoing radiotherapy at the Department of Clinical Oncology, Alexandria University, Egypt. Patients were assigned equally to either control group who received conventional treatment or test group who received 20 mg of melatonin along with the conventional treatment. All patients were clinically evaluated for oral mucositis severity and pain at three and six weeks after the start of radiotherapy. Additionally, the total antioxidant capacity (TAC) in patients' saliva samples was assessed at the start of radiotherapy and six weeks later. RESULTS: 92.5% of all patients have experienced oral mucositis with more severity reported in the control group (30%) compared with the test group (5%). Mean pain scores decreased significantly, in the second assessment, in test group rather than the controls. TAC values showed a significant difference between the test and controls with a significant decrease in TAC in the control group. CONCLUSION: The administration of melatonin with conventional treatment has reduced severe oral mucositis development. It aided in decreasing pain and hindering the reduction of TAC resulting from radiotherapy among the test group compared with controls.

Medical Subject Headings (MeSH)
AntioxidantsHead and Neck NeoplasmsHumansMelatoninRadiation InjuriesSalivaStomatitis
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality75/10
Citation Metrics
Total Citations44
Citations/Year8.8
Relative Citation Ratio3.77
NIH Percentile89.2%
Research Impact Scores
APT Score0.75
Weight Score2.47
Normalized Score0.69
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