A Phase 4 interventional study of N-acetylcysteine in Head and Neck Neoplasms, sponsored by University of Campinas, Brazil. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-09-16.
Sponsored by University of Campinas, Brazil · Phase 4, Interventional, and Supportive care
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.)
2,347 studies on the registry are indexed under Head and Neck Neoplasms; 553 are open to participants now.
This study's planned enrollment of 60 is above the median of 47 across 1,753 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
The patients will be treated with placebo as follows: 15 mL (0 mg 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).
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).
Drug: N-acetylcysteine
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
This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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University of Campinas, Brazil