THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS

NCT02241876 | Unknown Phase 4

• 1 other identifier: NAC+Cisplatin2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.)

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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

  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

  1 day

Secondary Outcomes (3)

• Quality of Life

  21 days

• Cellular and plasma oxidative stress biomarkers

  1 day

• Effectiveness of anticancer therapy

  1 day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

N-Acetylcysteine

EXPERIMENTAL

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

Interventions

N-acetylcysteine DRUG

N-Acetylcysteine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• severe psychiatric diseases
• impossibility of verbal communication
• without caregivers or companions

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

State University of Campinas - UNICAMP, Hospital das Clinicas

Campinas, São Paulo, 13083-888, Brazil

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

BR (1)