Prophylaxis with oral zinc sulfate against radiation-induced oropharyngeal mucositis in patients with head and neck cancer: Protocol for a meta-analysis of randomized controlled trials

Ting Shuai, Li-Juan Yi, Xu Tian, Wei-Qing Chen, Hui Chen, Xiu-E Li, Ting Shuai, Li-Juan Yi, Xu Tian, Wei-Qing Chen, Hui Chen, Xiu-E Li

Abstract

Background: Oropharyngeal mucositis is considered to be an inevitable and the most troubling side effect of head and neck irradiation, which is caused by the direct toxic action of radiation on oral mucosa. Several randomized controlled trials (RCTs) have investigated the efficacy of zinc sulfate in prevention of radiation-induced oropharyngeal mucositis in patients with head and neck cancer. However, the definite conclusions have not been confirmed. The systematic review and meta-analysis will be performed to comprehensively evaluate whether zinc sulfate is effective in prevention of radiation-induced oropharyngeal mucositis in patients with head and neck cancer.

Methods: Relevant information will be identified by a comprehensive search of the following electronic databases: PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and EBSCO from their inception to October 2018. Only RCTs which evaluated whether zinc sulfate is effective in prevention of radiation-induced oropharyngeal mucositis in patients with head and neck cancer will be eligible. Two independent investigators will be assigned to search literature, screen information, extract data, and appraise the risk of bias. The primary investigator will use Revman 5.3 software to perform all statistical analyses. We designed this systematic review and meta-analysis on June 5. 2018, and expect to complete the full-text on December 20, 2018.

Results: This protocol has been registered with a unique identifier of CRD42018108533. We will submit this systematic review and meta-analysis to a peer-reviewed journal. Meanwhile, we also will dissemination the whole findings in topic-related conferences.

Conclusion: As the first systematic review and metaanalysis, the present study will elucidate current evidence of the role of oral zinc for the prevention and treatment of radiation-induced oropharyngeal mucositis in the head and neck cancer.

Figures

Figure 1
Figure 1
The process of the whole study.
Figure 2
Figure 2
The PRISMA flow chart to depict the process of searching and screening citations.

References

    1. McGuire S. World Cancer Report 2014. Geneva, Switzerland: World Health Organization, International Agency for Research on Cancer, WHO Press, 2015. Adv Nutr 2016;7:418–9.
    1. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;0:1–31.
    1. De Sanctis V, Bossi P, Sanguineti G, et al. Mucositis in head and neck cancer patients treated with radiotherapy and systemic therapies: Literature review and consensus statements. Crit Rev Oncol Hematol 2016;100:147–66.
    1. Moslemi D, Nokhandani AM, Otaghsaraei MT, et al. Management of chemo/radiation-induced oral mucositis in patients with head and neck cancer: a review of the current literature. Radiother Oncol 2016;120:13–20.
    1. Belgioia L, Bacigalupo A, Alterio D, et al. Management of oropharyngeal mycosis in head and neck cancer occurring during (chemo) radiotherapy: an Italian radio-oncologist survey. Tumori 2015;101:312–7.
    1. Naidu MU, Ramana GV, Rani PU, et al. Chemotherapy-induced and/or radiation therapy-induced oral mucositis–complicating the treatment of cancer. Neoplasia (New York, N Y) 2004;6:423–31.
    1. Trotti A, Bellm LA, Epstein JB, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol 2003;66:253–62.
    1. Sutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys 2001;49:917–30.
    1. Moslemi D, Babaee N, Damavandi M, et al. Oral zinc sulphate and prevention of radiation-induced oropharyngealmucositis in patients with head and neck cancers: a double blind, randomized controlled clinical trial. Int J Radiat Res 2014;12:235–42.
    1. Kam AY, McMillan AS, Pow EH, et al. A preliminary report on patient acceptance of a novel intra-oral lubricating device for the management of radiotherapy-related xerostomia. Clin Oral Investig 2005;9:148–53.
    1. La RPA, Epstein JB, Trotti A, et al. Complications of radiation therapy for head and neck cancers. Cancer Nurs 2002;25:461–7.
    1. Elting LS, Cooksley C, Chambers M, et al. The burdens of cancer therapy. Clinical and economic outcomes of chemotherapy-induced mucositis. Cancer 2003;98:1531–9.
    1. Motallebnejad M, Akram S, Moghadamnia A, et al. The effect of topical application of pure honey on radiation-induced mucositis: a randomized clinical trial. J Contemp Dent Pract 2008;9:40–7.
    1. Sciubba JJ, Goldenberg D. Oral complications of radiotherapy. Lancet Oncol 2006;7:175–83.
    1. Rambod M, Pasyar N, Ramzi M. The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. Eur J Oncol Nurs 2018;33:14–21.
    1. Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol 2015;27:159–64.
    1. Garofalo JA, Erlandson E, Strong EW, et al. Serum zinc, serum copper, and the Cu/Zn ratio in patients with epidermoid cancers of the head and neck. J Surg Oncol 1980;15:381–6.
    1. Gruber S, Frings K, Kuess P, et al. Protective effects of systemic dermatan sulfate treatment in a preclinical model of radiation-induced oral mucositis. Strahlenther Onkol 2018;194:675–85.
    1. Ertekin MV, Koc M, Karslioglu I, et al. The effects of oral zinc sulphate during radiotherapy on anti-oxidant enzyme activities in patients with head and neck cancer: a prospective, randomised, placebo-controlled study. Int J Clin Pract 2004;58:662–8.
    1. Mosalaei A, Nasrolahi H, Ahmadloo N, et al. Effect of oral zinc sulphate in preventionof radiation induced oropharyngealmucositis during and after radiotherapyin patients with head and neck cancers. Middle East J Cancer 2010;1:69–76.
    1. Gorgu S, Ilknur A, Sercan O, et al. The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patents with head and neck cancer. Int J Radiation Res 2013;111–6.
    1. Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ (Clinical research ed ) 2015;350:g7647.
    1. Higgins JPT, Green S. (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from .
    1. Sonis ST. Method and apparatus for assessing oral mucositis, WO, 2005.
    1. Trotti A, Byhardt R, Stetz J, et al. Common toxicity criteria: version 2.0. an improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys 2000;47:13–47.
    1. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009;151:264–9.
    1. Wang L, Shuai T, Wang YY, Cao H. The effect of traditional Chinese medicine washing combined with massage for neonatal jaundice: a meta-analysis. TMR Integr Nur 2017;1:36–44.
    1. DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clinical Trials 1986;7:177–88.
    1. Bowden J, Tierney JF, Copas AJ, et al. Quantifying, displaying and accounting for heterogeneity in the meta-analysis of RCTs using standard and generalised Q statistics. BMC Med Res Methodol 2011;11:41.
    1. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002;21:1539–58.
    1. Palma PS, Delgado RM. Practical considerations on detection of publication bias. Gac Sanit 2006;20:10–6.
    1. Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34.
    1. Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Effect of low-level laser therapy on patient reported measures of oral mucositis and quality of life in head and neck cancer patients receiving chemoradiotherapy–a randomized controlled trial. Support Care Cancer 2013;21:1421–8.
    1. Alterio D, Jereczek-Fossa BA, Fiore MR, et al. Cancer treatment-induced oral mucositis. Anticancer Res 2007;27:1105–25.
    1. Lee S. Mineral derivatives in alleviating oral mucositis during cancer therapy: a systematic review. PeerJ 2015;3:e765.

Source: PubMed

3
Se inscrever