drugset / Trial / NCT03833570
Melatonin for Prevention of Radiation Induced Oral Mucositis
RandomizedParallel-groupOpen-labelPrevention
Summary
The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.
Timeline
- Start
- 2018-01-12
- Primary completion
- 2018-11-09
- Completion
- 2018-12-01
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Background Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8.
- 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.
- Background Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.
- 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.
- 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.
- 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.
- 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/
- 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.
- 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.
- 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.
- Background 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.
- Background Najeeb S, Khurshid Z, Zohaib S, Zafar MS. Therapeutic potential of melatonin in oral medicine and periodontology. Kaohsiung J Med Sci. 2016 Aug;32(8):391-6. doi: 10.1016/j.kjms.2016.06.005. Epub 2016 Jul 25.
- 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.
- 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.
- 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.
- 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.
- Background Mihandoost E, Shirazi A, Mahdavi SR, Aliasgharzadeh A. Can melatonin help us in radiation oncology treatments? Biomed Res Int. 2014;2014:578137. doi: 10.1155/2014/578137. Epub 2014 May 11.
- Background Shirzad A, Pouramir M, Seyedmajidi M, Jenabian N, Bijani A, Motallebnejad M. Salivary total antioxidant capacity and lipid peroxidation in patients with erosive oral lichen planus. J Dent Res Dent Clin Dent Prospects. 2014 Winter;8(1):35-9. doi: 10.5681/joddd.2014.006. Epub 2014 Mar 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | BBC | Unknown | — | Topical |
| Background | Miconaz | Unknown | — | — |
| Background | Oracure | Unknown | — | Topical |