THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS
- Registration Number
- NCT02241876
- Lead Sponsor
- University of Campinas, Brazil
- Brief 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.)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- head and neck cancer
- anticancer treatment - cisplatin (80 to 100 mg/m²) plus radiotherapy
- patients without previous treatment of head and neck cancer (surgery, chemotherapy and radiotherapy)
- severe psychiatric diseases
- impossibility of verbal communication
- without caregivers or companions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description N-Acetylcysteine N-acetylcysteine The patients will be treated with n-acetylcysteine as follows: 15 mL (600mg of drug), once a day, during 7 days in each cycle (2 days before chemotherapy with cisplatin, on the day of chemotherapy and more 4 days after chemotherapy).
- Primary Outcome Measures
Name Time Method Hematologic, Nephro, and Hepato Toxicity - Degree of toxicity by Common Toxicity Criteria for Adverse Effects (CTCAE - version 4.0) 120 hours 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)Gastrointestinal Toxicity - Degree of toxicity by CTCAE (version 4.0) 1 day Nausea, Vomiting and Diarrhea The time frame is on day 1 and up to 120 hours post-dose (each cycle)
audiometric testing 1 day audiometric testing for identification of ototoxic hearing loss. The time frame is prior to day 1 and 30 days after treatment completion
Nephrotoxicity 1 day The nephrotoxicity will be evaluated by EDTA-51Cr. The time frame are prior to day 1 and 30 days after treatment completion
- Secondary Outcome Measures
Name Time Method Quality of Life 21 days 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
Cellular and plasma oxidative stress biomarkers 1 day Time frame are Before day 1; 120 hours post-dose and 20 days post-dose (each cycle of chemotherapy)
Effectiveness of anticancer therapy 1 day 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
Trial Locations
- Locations (1)
State University of Campinas - UNICAMP, Hospital das Clinicas
🇧🇷Campinas, São Paulo, Brazil