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Evaluation of the use of N-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and neck cancer patients

Grant number: 14/04744-7
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): November 01, 2014
Effective date (End): May 31, 2017
Field of knowledge:Health Sciences - Pharmacy
Cooperation agreement: Coordination of Improvement of Higher Education Personnel (CAPES)
Principal researcher:Patricia Moriel
Grantee:Marília Berlofa Visacri
Home Institution: Faculdade de Ciências Médicas (FCM). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil


Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as the oral cavity, pharynx and larynx. The most effective treatment consists of high doses of cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities caused mainly by oxidative stress. The objective of this study will be evaluate the use of n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital / UNICAMP. Head and neck cancer patients who will begin cisplatin antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will be included in this research. They will be studied in 2 groups (n-acetylcisteine and placebo). All patients will be evaluated in relation to cisplatin induced hematologic and gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated measures tests (p<0.05.) (AU)

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Scientific publications
(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)
VISACRI, MARILIA B.; QUINTANILHA, JULIA C. F.; DE SOUSA, VANESSA M.; AMARAL, LAIS S.; AMBROSIO, ROSIANE DE F. L.; CALONGA, LUCIANE; CURI, SILVIA F. B. B.; LEME, MAYRA F. DE T.; CHONE, CARLOS T.; ALTEMANI, JOAO M. C.; MAZZOLA, PRISCILA G.; MALAGUTI, CARINA; VERCESI, ANIBAL E.; LIMA, CARMEN S. P.; MORIEL, PATRICIA. Can acetylcysteine ameliorate cisplatin-induced toxicities and oxidative stress without decreasing antitumor efficacy? A randomized, double-blind, placebo-controlled trial involving patients with head and neck cancer. CANCER MEDICINE, v. 8, n. 5, p. 2020-2030, MAY 2019. Web of Science Citations: 0.
FRANCA QUINTANILHA, JULIA COELHO; VISACRI, MARILIA BERLOFA; AMARAL, LAIS SAMPAIO; PASSOS LIMA, CARMEN SILVIA; CINTRA, MARIA LETICIA; MORIEL, PATRICIA. Leukocytoclastic vasculitis complicating cisplatin plus radiation treatment for laryngeal cancer: a case report. BMC CANCER, v. 17, DEC 6 2017. Web of Science Citations: 0.
VISACRI, MARILIA BERLOFA; PINCINATO, EDER DE CARVALHO; FERRARI, GRAZIELE BALDAN; FRANCA QUINTANILHA, JULIA COELHO; MAZZOLA, PRISCILA GAVA; PASSOS LIMA, CARMEN SILVIA; MORIEL, PATRICIA. Adverse drug reactions and kinetics of cisplatin excretion in urine of patients undergoing cisplatin chemotherapy and radiotherapy for head and neck cancer: a prospective study. DARU-JOURNAL OF PHARMACEUTICAL SCIENCES, v. 25, APR 24 2017. Web of Science Citations: 5.
Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)

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