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

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

SUBMITTER: Tian X

PROVIDER: S-EPMC6392683 | biostudies-other | 2018 May

REPOSITORIES: biostudies-other

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

Tian Xu X Chen Wei-Qing WQ Liu Xiao-Ling XL Pi Yuan-Ping YP Chen Hui H

Medicine 20180501 21

<h4>Background</h4>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.<h4>Met ...[more]

PMID: 29794779

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Project description:Chemotherapy-induced oral mucositis is an extremely serious complication faced by cancer patients. The role of oral zinc sulfate in preventing and treating chemotherapy-induced oral mucositis remains a subject of debate. The aim of this systematic review is to assess the potential of oral zinc sulfate to alleviate this morbid condition. A systematic search was conducted electronically in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) to capture all potential randomized controlled trials investigating efficacy and safety of oral zinc sulfate in prevention and treatment of chemotherapy-induced oral mucositis, and the retrieval time was limited from their inception to April 2018. We assigned two independent investigators to perform a search, screen citations, extract information, and evaluate the risk of bias in all included trials. Subsequently, the RevMan 5.3 software was utilized to perform all statistical analyses. We included five eligible studies involving 352 patients. Meta-analysis based on limited data revealed that oral zinc sulfate failed to decrease the incidence of chemotherapy-induced oral mucositis (RR [relative risk] = 0.52, 95% CI [confidence interval] = 0.17-1.64) as well as relieve chemotherapy-induced oral mucositits grade (RR = 0.62, 95% CI = 0.11-3.56; RR = 0.70, 95% CI = 0.29-1.71). Moreover, qualitative analyses also suggested that oral zinc sulfate was not associated with reduced oral pain intensity, delayed onset of chemotherapy-induced oral mucositis, decreased adverse events, or improved quality of life compared with control regimes. Oral zinc sulfate may not provide clinical benefits in preventing or reducing incidence, severity, or pain intensity of chemotherapy-induced oral mucositis in cancer patients. However, more studies with large-scale and rigorous methods are warranted for the purpose of further investigating efficacy and safety of oral zinc sulfate for this pathologic condition due to the presence of limitations.

Project description:BACKGROUND:Gastrointestinal mucosal injury (mucositis), commonly affecting the oral cavity, is a clinically significant yet incompletely understood complication of cancer chemotherapy. Although antineoplastic cytotoxicity constitutes the primary injury trigger, the interaction of oral microbial commensals with mucosal tissues could modify the response. It is not clear, however, whether chemotherapy and its associated treatments affect oral microbial communities disrupting the homeostatic balance between resident microorganisms and the adjacent mucosa and if such alterations are associated with mucositis. To gain knowledge on the pathophysiology of oral mucositis, 49 subjects receiving 5-fluorouracil (5-FU) or doxorubicin-based chemotherapy were evaluated longitudinally during one cycle, assessing clinical outcomes, bacterial and fungal oral microbiome changes, and epithelial transcriptome responses. As a control for microbiome stability, 30 non-cancer subjects were longitudinally assessed. Through complementary in vitro assays, we also evaluated the antibacterial potential of 5-FU on oral microorganisms and the interaction of commensals with oral epithelial tissues. RESULTS:Oral mucositis severity was associated with 5-FU, increased salivary flow, and higher oral granulocyte counts. The oral bacteriome was disrupted during chemotherapy and while antibiotic and acid inhibitor intake contributed to these changes, bacteriome disruptions were also correlated with antineoplastics and independently and strongly associated with oral mucositis severity. Mucositis-associated bacteriome shifts included depletion of common health-associated commensals from the genera Streptococcus, Actinomyces, Gemella, Granulicatella, and Veillonella and enrichment of Gram-negative bacteria such as Fusobacterium nucleatum and Prevotella oris. Shifts could not be explained by a direct antibacterial effect of 5-FU, but rather resembled the inflammation-associated dysbiotic shifts seen in other oral conditions. Epithelial transcriptional responses during chemotherapy included upregulation of genes involved in innate immunity and apoptosis. Using a multilayer epithelial construct, we show mucositis-associated dysbiotic shifts may contribute to aggravate mucosal damage since the mucositis-depleted Streptococcus salivarius was tolerated as a commensal, while the mucositis-enriched F. nucleatum displayed pro-inflammatory and pro-apoptotic capacity. CONCLUSIONS:Altogether, our work reveals that chemotherapy-induced oral mucositis is associated with bacterial dysbiosis and demonstrates the potential for dysbiotic shifts to aggravate antineoplastic-induced epithelial injury. These findings suggest that control of oral bacterial dysbiosis could represent a novel preventive approach to ameliorate oral mucositis.

Dataset Information

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

Publications

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

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