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.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
State University of Campinas - UNICAMP, Hospital das Clinicas
Campinas, São Paulo, Brazil
Hematologic, Nephro, and Hepato Toxicity - Degree of toxicity by Common Toxicity Criteria for Adverse Effects (CTCAE - version 4.0)
Hematologic - anemia, leukopenia, neutropenia, lymphopenia, thrombocytopenia; Nephrotoxicity - increase of serum creatinine level and reduction of creatinine clearance; Hepatotoxicity - increase of AST, ALT, ALP, GGT, Total Bilirubin levels. The time frame is 120 hours post-dose and 20 days post-dose (each cycle of Chemotherapy)
Time frame: 120 hours
Gastrointestinal Toxicity - Degree of toxicity by CTCAE (version 4.0)
Nausea, Vomiting and Diarrhea The time frame is on day 1 and up to 120 hours post-dose (each cycle)
Time frame: 1 day
audiometric testing
audiometric testing for identification of ototoxic hearing loss. The time frame is prior to day 1 and 30 days after treatment completion
Time frame: 1 day
Nephrotoxicity
The nephrotoxicity will be evaluated by EDTA-51Cr. The time frame are prior to day 1 and 30 days after treatment completion
Time frame: 1 day
Quality of Life
Quality of Life by EORTC-QLQ- 30 and EORTC-QLQ-H\&N35 questionnaires The time frame are Day, 1, 22, 43, and 21 days after treatment completion
Time frame: 21 days
Cellular and plasma oxidative stress biomarkers
Time frame are Before day 1; 120 hours post-dose and 20 days post-dose (each cycle of chemotherapy)
Time frame: 1 day
Effectiveness of anticancer therapy
The effectiveness of anticancer therapy will be analyzed by Computed Tomography of the head and neck. The time frame are prior to day 1 and 30 days after treatment completion
Time frame: 1 day
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