Efficacy and safety of oral zinc sulfate in the prevention of chemotherapy-induced oral mucositis: Protocol for a meta-analysis of randomized controlled trials

Xu Tian, Wei-Qing Chen, Xiao-Ling Liu, Yuan-Ping Pi, Hui Chen, Xu Tian, Wei-Qing Chen, Xiao-Ling Liu, Yuan-Ping Pi, Hui Chen

Abstract

Background: Oral mucositis has been an extremely serious complication resulted from cytotoxic effects of the chemotherapy among cancer patients. Several randomized controlled trials investigated the efficacy of zinc sulfate in prevention of this morbid condition among cancer patients undergoing chemotherapy, however conclusive findings has not yet been generated. This systematic review will assess the efficacy and safety of oral zinc sulfate for chemotherapy-induced oral mucositis.

Methods: We will electronically search all potential citations in PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) from their inception to April 2018. The randomized controlled trials, which investigated the efficacy of oral zinc sulfate for chemotherapy-induced oral mucositis will be considered. We will assign 2 independent investigators to perform search, screen citations, extract data, and appraise risk of bias. And then, the primary investigator will adopt RevMan 5.3 software to complete all statistical analyses.

Ethics and dissemination: The findings from this systematic review and meta-analysis will be submitted to a peer-reviewed journal for publication. Moreover, we will disseminate all results in any topic-related conference.

Registration number: This protocol has been registered with a number of CRD42018093605.

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Process of the systematic review and meta-analysis. CENTRAL = Cochrane Central Register of Controlled Trials, RCTs = randomized controlled trials, RR = relative risk, MD = mean difference.
Figure 2
Figure 2
PRISMA flow chart. PRISMA = preferred reporting items for systematic reviews and meta-analysis. This process will be completed by two independent reviewers according to the inclusion and exclusion criteria.

References

    1. Rodríguezcaballero A, Torreslagares D, Roblesgarcía M, et al. Cancer treatment-induced oral mucositis: a critical review. Int J Oral Maxillofac Surg 2012;41:225–38.
    1. Raber-Durlacher JE, Elad S, Barasch A. Oral mucositis. Oral Oncol 2010;46:452–6.
    1. Ibraheemi AAA, Shamoun S. Incidence and risk factors of oral mucositis in patients with breast cancer who receiving chemotherapy in Al-Bashir Hospital. Int J Hematol Oncol Stem Cell Res 2016;10:217–23.
    1. Martinez JM, Pereira D, Chacim S, et al. Mucositis care in acute leukemia and non-Hodgkin lymphoma patients undergoing high-dose chemotherapy. Support Care Cancer 2014;22:2563–9.
    1. Gholizadeh N, Sheykhbahaei N, Sadrzadeh-Afshar MS. New treatment approaches of oral mucositis: a review of literature. Adv Hum Biol 2016;6:66–72.
    1. Raberdurlacher JE, Elad S, Barasch A. Oral mucositis. Oral Oncol 2010;46:452–6.
    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. Alterio D, Jereczek-Fossa BA, Fiore MR, et al. Cancer treatment-induced oral mucositis. Anticancer Res 2007;27:1105–25.
    1. Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol 2015;27:159–64.
    1. Skrovanek S, Diguilio K, Bailey R, et al. Zinc and gastrointestinal disease. World J Gastrointest Pathophysiol 2014;5:496–513.
    1. Arbabikalati F, Arbabikalati F, Deghatipour M, et al. Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: a double-blind randomized clinical trial. Arch Iran Med 2012;15:413–7.
    1. Gholizadeh N, Chavashi H, Kahani S, et al. The effect of orally-administered zinc in the prevention of chemotherapy-induced oral mucositis in patients with acute myeloid leukemia. Int J Cancer Manag 2017;10:e9252.
    1. Mansouri A, Hadjibabaie M, Iravani M, et al. The effect of zinc sulfate in the prevention of high-dose chemotherapy-induced mucositis: a double-blind, randomized, placebo-controlled study. Hematol Oncol 2012;30:22–6.
    1. Mehdipour M, Zenoz AT, Kermani IA, et al. A comparison between zinc sulfate and chlorhexidine gluconate mouthwashes in the prevention of chemotherapy-induced oral mucositis. Daru 2011;19:71–3.
    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 2015;350:g7647.
    1. Higgins JP, Green S. Cochrane Handbook For Systematic Reviews of Interventions Version 5.0.0. Naunyn Schmiedebergs Arch Pharmacol 2009;210:S38.
    1. Palmer MK. WHO Handbook for Reporting Results of Cancer Treatment. Br J Cancer 1982;45:484–5.
    1. Spijkervet FKL, Saene HKFV, Panders AK, et al. Scoring irradiation mucositis in head and neck cancer patients. J Oral Pathol Med 1989;18:167–71.
    1. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009;6:e1000097.
    1. Zeng X, Zhang Y, Kwong JS, et al. The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review. J Evid Based Med 2015;8:2–10.
    1. Dersimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clin Trials 1986;7:177.
    1. Tierney JF, Jack B, 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. Gaceta Sanitaria 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. Worthington HV, Clarkson JE, Bryan G, et al. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev 2011;4:CD000978.
    1. Forastiere AA. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med 2004;350:1937–44.
    1. Ezra P, Noã«L G, Mazeron JJ. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. Cancer Radiother 2000;92:324–5.
    1. Kwon Y. Mechanism-based management for mucositis: option for treating side effects without compromising the efficacy of cancer therapy. Onco Targets Ther 2016;9(Issue 1):2007–16.
    1. Ertekin MV, Koç M, Karslioğlu I, et al. Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study. Int J Radiat Oncol Biol Phys 2004;58:167–74.
    1. Cheng KKF, Molassiotis A, Chang AM, et al. Evaluation of an oral care protocol intervention in the prevention of chemotherapy-induced oral mucositis in paediatric cancer patients. Eur J Cancer 2001;37:2056–63.
    1. Haase H, Overbeck S, Rink L. Zinc supplementation for the treatment or prevention of disease: current status and future perspectives. Experimen Gerontol 2008;43:394–408.
    1. Sonis ST. The pathobiology of mucositis. Nature Rev Cancer 2004;4:277–84.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren