THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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 dose 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 /
University of Campinas (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-acetylcysteine 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.)