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| Name | Class |
|---|---|
| Alexandria University | OTHER |
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The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin therapy | Experimental | Rapid Release Capsules Melatonin, 10 mg in combination with the symptomatic treatment Symptomatic treatment which included:
Melatonin capsules dose: Two tablets,30 minutes before sleeping once daily for six weeks Symptomatic treatment dose: Three times a day for six weeks |
|
| Conventional therapy | Active Comparator | Conventional therapy (symptomatic treatment) which included:
Dose: Three times a day for six weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | 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;
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21133051 | Background | 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. | |
| 15782422 | Background | 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. |
| Label | URL |
|---|---|
| WHO Handbook for Reporting Results of Cancer Treatment | View source |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Miconaz oral gel | Drug | Antifungal agent |
|
| BBC oral spray | Drug | Topical anesthetics and anti-inflammatory agent |
|
| Oracure gel | Drug | Topical analgesic gel |
|
| Alkamisr sachets | Other | Sodium bicarbonate mouthwash |
|
| up to 3 and 6 weeks |
| 24772297 | Background | 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. |
| 18360600 | Background | 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. |
| 28589080 | Background | 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. |
| 15605918 | Background | Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8. |
| 24744571 | Background | 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. |
| 25774860 | Background | Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180. |
| 17923929 | Background | Volpato LE, Silva TC, Oliveira TM, Sakai VT, Machado MA. Radiation therapy and chemotherapy-induced oral mucositis. Braz J Otorhinolaryngol. 2007 Jul-Aug;73(4):562-8. doi: 10.1016/s1808-8694(15)30110-5. |
| 24614837 | Background | Moslehi A, Taghizadeh-Ghehi M, Gholami K, Hadjibabaie M, Jahangard-Rafsanjani Z, Sarayani A, Javadi M, Esfandbod M, Ghavamzadeh A. N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: a double-blind, randomized, placebo-controlled trial. Bone Marrow Transplant. 2014 Jun;49(6):818-23. doi: 10.1038/bmt.2014.34. Epub 2014 Mar 10. |
| 16219483 | Background | Hardeland R, Pandi-Perumal SR, Cardinali DP. Melatonin. Int J Biochem Cell Biol. 2006 Mar;38(3):313-6. doi: 10.1016/j.biocel.2005.08.020. Epub 2005 Sep 27. |
| 26844312 | Background | Brasure M, MacDonald R, Fuchs E, Olson CM, Carlyle M, Diem S, Koffel E, Khawaja IS, Ouellette J, Butler M, Kane RL, Wilt TJ. Management of Insomnia Disorder [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Dec. Report No.: 15(16)-EHC027-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK343503/ |
| 23044640 | Background | 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. |
| 22429105 | Background | 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. |
| 19630367 | Background | Zisapel N. [Controlled release melatonin (Circadin) in the treatment of insomnia in older patients: efficacy and safety in patients with history of use and non-use of hypnotic drugs]. Harefuah. 2009 May;148(5):337-41, 348. Hebrew. |
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| 22271210 | Background | Wang YM, Jin BZ, Ai F, Duan CH, Lu YZ, Dong TF, Fu QL. The efficacy and safety of melatonin in concurrent chemotherapy or radiotherapy for solid tumors: a meta-analysis of randomized controlled trials. Cancer Chemother Pharmacol. 2012 May;69(5):1213-20. doi: 10.1007/s00280-012-1828-8. Epub 2012 Jan 24. |
| 3078045 | Background | McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934. |
| 11328833 | Background | Koracevic D, Koracevic G, Djordjevic V, Andrejevic S, Cosic V. Method for the measurement of antioxidant activity in human fluids. J Clin Pathol. 2001 May;54(5):356-61. doi: 10.1136/jcp.54.5.356. |
| 20587949 | Background | 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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| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |