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Local tissue electrical parameters predict oral mucositis in HNSCC patients: A diagnostic accuracy double-blind, randomized controlled trial.

ABSTRACT: Oral Mucositis (OM) is a common adverse effect of head and neck squamous cell carcinoma (HNSCC) treatment. The purpose of this study was to investigate the significance of early changes in tissue electrical parameters (TEPs) in predicting the development of OM in HNSCC patients receiving radiation therapy (RT). The current study combined two study designs. The first was a case-control study. The control group comprised of RT patients who did not receive head and neck RT, and patients with HNSCC who received RT comprised the case group. In the second part of the study, the case group was included in a parallel cohort. A total of 320 patients were assessed for eligibility, and 135 patients were enrolled. Double blinding was performed, and neither the patients nor the care providers knew the measured parameters. The primary outcome was the detection of between-group changes in local TEPs over the follow-up period. The secondary outcome was the appearance of OM grades II, III, or IV and the predictive value of local TEPs in determining the incidence of OM after RT. The variables, impedance module, resistance, reactance, phase angle, and capacitance, were analyzed by the receiver operator curves (ROC). The case and control groups did not differ in demographic and clinical characteristics. Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups. Evaluation of TEPs in the first week of RT correlated with the development of OM lesions during cancer therapy. ROC analysis showed that local impedance module and resistance presented higher specificity than did other parameters in predicting OM. In conclusion, local tissue electrical parameters measured at the first RT week can be useful tools to predict oral mucositis.

SUBMITTER: Sanches GLG

PROVIDER: S-EPMC7293345 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Local tissue electrical parameters predict oral mucositis in HNSCC patients: A diagnostic accuracy double-blind, randomized controlled trial.

Sanches Gabriela Luize Guimarães GLG da Silva Menezes Agna Soares AS Santos Laércio Ives LI Durães Cristina Paixão CP Fonseca Larissa Lopes LL Baldo Marcelo Perim MP de Oliveira Faria Thais T de Araújo Andrade Luciano Alves LA Ekel Petr Iakovlevitch PI Santos Sérgio Henrique Sousa SHS de Paula Alfredo Maurício Batista AMB Farias Lucyana Conceição LC D'Angelo Marcos Flávio Silveira Vasconcelos MFSV Guimarães André Luiz Sena ALS

Scientific reports 20200612 1

Oral Mucositis (OM) is a common adverse effect of head and neck squamous cell carcinoma (HNSCC) treatment. The purpose of this study was to investigate the significance of early changes in tissue electrical parameters (TEPs) in predicting the development of OM in HNSCC patients receiving radiation therapy (RT). The current study combined two study designs. The first was a case-control study. The control group comprised of RT patients who did not receive head and neck RT, and patients with HNSCC ...[more]

PMID: 32533013

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Project description:BackgroundDenture-related stomatitis (DS) is chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganisms held together by a mucus-like matrix of carbohydrate that adheres to different surfaces, including the denture surface. DS has recently been correlated with deleterious cardiovascular alterations. The potential effect of hygiene protocols in the control of DS and randomized clinical trials that address this oral condition with cardiovascular complications are important in clinical decision-making.Material/designA clinical trial, randomized, double-blind, and with parallel groups, will be conducted in Brazil The sample will consist of 100 patients without teeth in both arches, users of at least maxillary complete dentures, and diagnosed with DS, who will be allocated to groups (n = 25 per group) according to the different hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% triclosan solution; (3) brushing of the palate and immersion of the prosthesis in lactose monohydrate; or (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate. The response variables will be heart rate variability and alteration of blood pressure (systemic level), remission of DS, removal of biofilm, reduction of microbial load (colony-forming units (CFU)), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein (CRP), viscosity, pH and salivary flow (locally); patient-centred qualitative analysis will also be undertaken. Measurements will be performed at baseline and 10 days after the interventions. The results obtained will be statistically analyzed as pertinent, with a level of significance of 0.05.DiscussionThis study will provide a guideline for clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm. Also, it may provide evidence of correlation of oral manifestation with cardiac risk.Trial registrationBrazilian Registry of Clinical Trials, RBR-4hhwjb. Registered on 9 November 2018.

Dataset Information

Local tissue electrical parameters predict oral mucositis in HNSCC patients: A diagnostic accuracy double-blind, randomized controlled trial.

Publications

Local tissue electrical parameters predict oral mucositis in HNSCC patients: A diagnostic accuracy double-blind, randomized controlled trial.

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