Melatonin for Prevention of Radiation Induced Oral Mucositis
NCT ID: NCT03833570
Last Updated: 2019-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2018-01-12
2018-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Melatonin therapy
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
Rapid 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.
Miconaz oral gel
Antifungal agent
BBC oral spray
Topical anesthetics and anti-inflammatory agent
Oracure gel
Topical analgesic gel
Alkamisr sachets
Sodium bicarbonate mouthwash
Conventional therapy
Conventional therapy (symptomatic treatment) which included:
* Miconaz oral gel
* BBC oral spray
* Oracure gel
* Alkamisr sachets
Dose: Three times a day for six weeks
Miconaz oral gel
Antifungal agent
BBC oral spray
Topical anesthetics and anti-inflammatory agent
Oracure gel
Topical analgesic gel
Alkamisr sachets
Sodium bicarbonate mouthwash
Interventions
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Rapid 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.
Miconaz oral gel
Antifungal agent
BBC oral spray
Topical anesthetics and anti-inflammatory agent
Oracure gel
Topical analgesic gel
Alkamisr sachets
Sodium bicarbonate mouthwash
Eligibility Criteria
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Inclusion Criteria
* 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 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.
25 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Hams Hamed Abdelrahman
OTHER
Responsible Party
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Hams Hamed Abdelrahman
Instructor of Dental Public Health
Principal Investigators
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Hossam H Abdelaziz Elsabbagh, BDS
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Eglal M Moussa, Phd
Role: STUDY_DIRECTOR
Alexandria University
Sabah AH Mahmoud, Phd
Role: STUDY_DIRECTOR
University of Alexandria
Rasha O Elsaka, Phd
Role: STUDY_DIRECTOR
University of Alexandria
Locations
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Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
Alexandria, , Egypt
Countries
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References
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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.
Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
Campos MI, Campos CN, Aarestrup FM, Aarestrup BJ. Oral mucositis in cancer treatment: Natural history, prevention and treatment. Mol Clin Oncol. 2014 May;2(3):337-340. doi: 10.3892/mco.2014.253. Epub 2014 Feb 7.
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.
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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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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Zhang HM, Zhang Y. Melatonin: a well-documented antioxidant with conditional pro-oxidant actions. J Pineal Res. 2014 Sep;57(2):131-46. doi: 10.1111/jpi.12162. Epub 2014 Aug 6.
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Rai B, Kaur J, Jacobs R, Singh J. Possible action mechanism for curcumin in pre-cancerous lesions based on serum and salivary markers of oxidative stress. J Oral Sci. 2010 Jun;52(2):251-6. doi: 10.2334/josnusd.52.251.
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Related Links
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WHO Handbook for Reporting Results of Cancer Treatment
Other Identifiers
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0008839
Identifier Type: -
Identifier Source: org_study_id
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