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

Sponsor

University of Campinas, Brazil (Other)

Overall Status

Unknown status

CT.gov ID

NCT02241876

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State University of Campinas - UNICAMP, Hospital das Clinicas	Campinas	São Paulo	Brazil	13083-888

Sponsors and Collaborators

University of Campinas, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patricia Moriel, PhD, University of Campinas, Brazil

ClinicalTrials.gov Identifier:

NCT02241876

Other Study ID Numbers:

NAC+Cisplatin2014

First Posted:

Sep 16, 2014

Last Update Posted:

Sep 16, 2014

Last Verified:

Sep 1, 2014

Additional relevant MeSH terms:

Head and Neck Neoplasms

Acetylcysteine

N-monoacetylcystine

Study Results

No Results Posted as of Sep 16, 2014