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

NCT ID: NCT02241876

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

Interventions

N-acetylcysteine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Patricia Moriel

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

State University of Campinas - UNICAMP, Hospital das Clinicas

Campinas, São Paulo, Brazil

Countries

Brazil

Facility Contacts

Patricial Moriel

Role: primary

morielpa@fcm.unicamp.br

55 (19) 35218884

Marília B Visacri

Role: backup

mariberlofa@gmail.com

55 (19) 35218884

Other Identifiers

NAC+Cisplatin2014

Identifier Type: -

Identifier Source: org_study_id