THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS
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|ClinicalTrials.gov Identifier: NCT02241876|
Recruitment Status : Unknown
Verified September 2014 by Patricia Moriel, University of Campinas, Brazil.
Recruitment status was: Not yet recruiting
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: N-acetylcysteine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||EVALUATION OF THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS IN HEAD AND NECK CANCER PATIENTS|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2016|
Placebo Comparator: Placebo
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).
- Hematologic, Nephro, and Hepato Toxicity - Degree of toxicity by Common Toxicity Criteria for Adverse Effects (CTCAE - version 4.0) [ Time Frame: 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) [ Time Frame: 1 day ]Nausea, Vomiting and Diarrhea The time frame is on day 1 and up to 120 hours post-dose (each cycle)
- audiometric testing [ Time Frame: 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 [ Time Frame: 1 day ]The nephrotoxicity will be evaluated by EDTA-51Cr. The time frame are prior to day 1 and 30 days after treatment completion
- Quality of Life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241876
|State University of Campinas - UNICAMP, Hospital das Clinicas||Not yet recruiting|
|Campinas, São Paulo, Brazil, 13083-888|
|Contact: Patricial Moriel 55 (19) 35218884 firstname.lastname@example.org|
|Contact: Marília B Visacri 55 (19) 35218884 email@example.com|
|Principal Investigator: Marilia B Visacri|