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Active natural products: clinical study of standardized Arrabidaea chica Verlot herbal medicine for mucositis treatment of head & neck cancer patients

Grant number: 15/08338-6
Support type:Regular Research Grants
Duration: November 01, 2015 - October 31, 2018
Field of knowledge:Health Sciences - Pharmacy
Principal Investigator:Mary Ann Foglio
Grantee:Mary Ann Foglio
Home Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

Oral mucositis (OM) is a side effect of some cancer treatments characterized by painful ulcerative lesions in the oral cavity. Local application of low intensity laser is effective in the prevention and treatment of OM with low costs of obtaining and maintenance of laser devices. Nevertheless, the lack of trained dentists difficult the use of this technique in routine Hospital Health System in Brazil requiring research of alternatives for OM treatment. Preliminary studies in rats, conducted by our research group, indicated an important healing activity of the ethanol extract of the leaves of Arrabidaea chica (EB) combined with a potential protective effect in mucositis model of the gastrointestinal tract induced by 5-fluorouracil. Genotoxicity and mutagenicity Literature data show that A. chica extract can be used safely in humans. The objective of this project is to understand possible signs of toxicity through adverse event reports of healthy patients after the use of adhesive mucus gel formulation containing crude extract of chica Arrabidaea, in theoral cavity, in clinical study for subsequent phase 2 and 3 studies. Phase 1 study will take 30 days, is an "open", all involved will have accurate knowledge about the procedures that will be submitted. The drug will be dispensed volunteers once a week, within 30 consecutive days in individual tubes for each application at different oral cavity regions, 3 times a day, or seven kits will be delivered weekly with twelve individual tubes containing sufficient product for an application by region, containing the 2.5% A. chica mucus gel extract adhesive mucus gel being applied three times daily, morning, noon and night, in four different regions of the oral mucosa. The tubes used will have to be stored and delivered to the investigator responsible to verify that there was the correct medication. Before each application volunteers should make oral hygiene by brushing and flossing and without food or water ingestion for 30 minutes after application. Thus, the study is expected to identify possible adverse effects of the crude extract making available an effective and low-cost alternative for OM treatment. (AU)

Scientific publications (4)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
LIMA, LONETA LAURO; TAKETA, THIAGO BEZERRA; BEPPU, MARISA MASUMI; DE OLIVEIRA SOUSA, ILZA MARIA; FOGLIO, MARY ANN; MORAES, ANGELA MARIA. Coated electrospun bioactive wound dressings: Mechanical properties and ability to control lesion microenvironment. Materials Science & Engineering C-Materials for Biological Applications, v. 100, p. 493-504, JUL 2019. Web of Science Citations: 4.
ALMEIDA QUEIROZ, NUBIA DE CASSIA; JORGE, MICHELLE PEDROZA; DE OLIVEIRA SOUSA, ILZA MARIA; PASSOS LIMA, CARMEN SILVIA; DE MIRANDA MATIAS, MARIA CHRISTINA; DAL RIO, ANA CRISTINA; PEREIRA, EDUARDO BALDON; KAKAS GALASSI, VICTORIA HAHN; DE CARVALHO, JOAO ERNESTO; GALVAO, TAIS FREIRE; FOGLIO, MARY ANN. Arrabidaea chica for oral mucositis in patients with head and neck cancer: a protocol of a randomised clinical trial. BMJ OPEN, v. 8, n. 10 OCT 2018. Web of Science Citations: 0.
PAULA, JULIA T.; SOUSA, ILZA M. O.; FOGLIO, MARY A.; CABRAL, FERNANDO A. Selective fractionation of extracts of Arrabidaea chica Verlot using supercritical carbon dioxide as antisolvent. JOURNAL OF SUPERCRITICAL FLUIDS, v. 133, n. 1, p. 9-16, MAR 2018. Web of Science Citations: 5.
BARBOSA, VALERIA AQUILINO; BAREA, PAULA; MAZIA, RENATA SESPEDE; UEDA-NAKAMURA, TANIA; DA COSTA, WILLIAN FERREIRA; FOGLIO, MARY ANN; GOES RUIZ, ANA LUCIA T.; DE CARVALHO, JOAO ERNESTO; VENDRAMINI-COSTA, DEBORA BARBOSA; NAKAMURA, CELSO VATARU; SARRAGIOTTO, MARIA HELENA. Synthesis and evaluation of novel hybrids beta-carboline-4-thiazolidinones as potential antitumor and antiviral agents. EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY, v. 124, p. 1093-1104, NOV 29 2016. Web of Science Citations: 16.

Please report errors in scientific publications list by writing to: cdi@fapesp.br.
Filed patent(s) as a result of this research project

PROCESSO PARA OBTENÇÃO DE MEMBRANAS POLIMÉRICAS POR ELECTROSPINNING, MEMBRANAS POLIMÉRICAS CONTENDO EXTRATOS DE PTERODON PUBESCENS BENTH E ARRABIDAEA CHICA VERLOT E SEUS USOS. BR1020160285062 - Universidade Estadual de Campinas (UNICAMP) . Tais Helena Costa Salles; Mary Ann Foglio; Fabiana Volpe Zanutto; Ilza Maria Oliveira Souza; Marcos Akira D'ávila - December 2016, 05

PROCESSO PARA OBTENÇÃO DE MEMBRANAS POLIMÉRICAS POR ELECTROSPINNING, MEMBRANAS POLIMÉRICAS CONTENDO EXTRATOS DE Pterodon pubescens Benth E Arrabidaea chica Verlot E SEUS USOS PCT/BR2017/000134 - Universidade Estadual de Campinas (UNICAMP) . Mary Ann Foglio; Marcos Akira d'Ávila; Ilza Maria Oliveira Souza; Fabiana Volpe Zanutto; Tais Helena Costa Salles - November 2017, 17