Melatonin for Prevention of Radiation Induced Oral Mucositis

NCT03833570 | Completed Phase 2

• 1 other identifier: 0008839
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis (Ulcerative) Due to Radiation

Keywords

Melatonin

Outcome Measures

Primary Outcomes (2)

• Changes in severity of oral mucositis at different time points along the study

  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)

  up to 3 and 6 weeks

• Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study

  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

  Baseline (day 0) and up to 6 weeks

Secondary Outcomes (1)

• Pain and discomfort severity at different time points along the study: Numeric Rating Scale

  up to 3 and 6 weeks

Study Arms (2)

Melatonin therapy

EXPERIMENTAL

Rapid Release Capsules Melatonin, 10 mg in combination with the symptomatic treatment Symptomatic treatment which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Melatonin capsules dose: Two tablets,30 minutes before sleeping once daily for six weeks Symptomatic treatment dose: Three times a day for six weeks

Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg; Drug: Miconaz oral gel; Drug: BBC oral spray; Drug: Oracure gel; Other: Alkamisr sachets

Conventional therapy

ACTIVE COMPARATOR

Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks

Drug: Miconaz oral gel; Drug: BBC oral spray; Drug: Oracure gel; Other: Alkamisr sachets

Interventions

Rapid Release Capsules Melatonin, 10 mg DIETARY_SUPPLEMENT

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.

Melatonin therapy

Miconaz oral gel DRUG

Antifungal agent

Conventional therapy; Melatonin therapy

BBC oral spray DRUG

Topical anesthetics and anti-inflammatory agent

Conventional therapy; Melatonin therapy

Oracure gel DRUG

Topical analgesic gel

Conventional therapy; Melatonin therapy

Alkamisr sachets OTHER

Sodium bicarbonate mouthwash

Conventional therapy; Melatonin therapy

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead
• Alexandria University: collaborator

Study Sites (1)

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

Related Publications (23)

• Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.

  PMID: 21133051 BACKGROUND

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• Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.

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• Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.

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• Lee CS, Ryan EJ, Doherty GA. Gastro-intestinal toxicity of chemotherapeutics in colorectal cancer: the role of inflammation. World J Gastroenterol. 2014 Apr 14;20(14):3751-61. doi: 10.3748/wjg.v20.i14.3751.

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• Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.

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• Lyseng-Williamson KA. Melatonin prolonged release: in the treatment of insomnia in patients aged >/=55 years. Drugs Aging. 2012 Nov;29(11):911-23. doi: 10.1007/s40266-012-0018-z.

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• Lemoine P, Zisapel N. Prolonged-release formulation of melatonin (Circadin) for the treatment of insomnia. Expert Opin Pharmacother. 2012 Apr;13(6):895-905. doi: 10.1517/14656566.2012.667076. Epub 2012 Mar 19.

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Related Links

• WHO Handbook for Reporting Results of Cancer Treatment

MeSH Terms

Conditions

Stomatitis; Ulcer

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Hossam H Abdelaziz Elsabbagh, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Eglal M Moussa, Phd

  Alexandria University

  STUDY DIRECTOR

• Sabah AH Mahmoud, Phd

  University of Alexandria

  STUDY DIRECTOR

• Rasha O Elsaka, Phd

  University of Alexandria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: February 7, 2019
• Study Start: January 12, 2018
• Primary Completion: November 9, 2018
• Study Completion: December 1, 2018
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)