Head and Neck Neoplasms
Conditions
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.)
Interventions
DRUGN-acetylcysteine
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* severe psychiatric diseases * impossibility of verbal communication * without caregivers or companions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Brazil
Outcome results
None listed