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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
Sponsor:
Information provided by (Responsible Party):
Patricia Moriel, 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.)

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: N-acetylcysteine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Experimental: 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).
Drug: N-acetylcysteine



Primary Outcome Measures :
  1. 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)


  2. 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)

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Brazil
State University of Campinas - UNICAMP, Hospital das Clinicas Not yet recruiting
Campinas, São Paulo, Brazil, 13083-888
Contact: Patricial Moriel    55 (19) 35218884    morielpa@fcm.unicamp.br   
Contact: Marília B Visacri    55 (19) 35218884    mariberlofa@gmail.com   
Principal Investigator: Marilia B Visacri         
Sponsors and Collaborators
University of Campinas, Brazil

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Responsible Party: Patricia Moriel, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02241876     History of Changes
Other Study ID Numbers: NAC+Cisplatin2014
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Acetylcysteine
Cisplatin
N-monoacetylcystine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes