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Sponsored by: |
Rijnstate Hospital |
---|---|
Information provided by: | Rijnstate Hospital |
ClinicalTrials.gov Identifier: | NCT00637624 |
In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for lungcancer with chemotherapy containing cisplatin.
Condition | Intervention |
---|---|
Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Lung Mesothelioma |
Drug: N-Acetylcysteine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Double-Blind Study of N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy in Patients Treated for (Non)Small Cell Lung Cancer and Malignant Mesothelioma |
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
N-Acetylcysteine
|
Drug: N-Acetylcysteine
oral 3 times daily 600 mg N-Acetylcysteine en intravenous once every 3 weeks 40 mg/kg
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo 3 times daily 600 mg and once every 3 weeks intravenous saline fluid
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Idris Bahce, M.D. | +31263788888 ext 3652 | IBahce@alysis.nl |
Contact: Hans Smit, MD | +31263788888 ext 3030 | HSmit@alysis.nl |
Netherlands, Gelderland | |
Rijnstate Hospital | |
Arnhem, Gelderland, Netherlands, 6800TA |
Principal Investigator: | Idris Bahce, MD | Rijnstate Hospital |
Responsible Party: | Rijnstate Hospital ( I Bahce ) |
Study ID Numbers: | LTC-510-100108-Bahce, CCMO: NL19614.091.07, EudraCT: 2007-002787-95 |
Study First Received: | March 11, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00637624 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Acetylcysteine Cisplatin Neuropathy Antioxidants |
Thoracic Neoplasms Neurotoxicity Syndromes Carcinoma, Neuroendocrine Neurotoxicity syndromes Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Neoplasms, Germ Cell and Embryonal Lung Diseases Acetylcysteine Neuroepithelioma Mesothelioma Adenocarcinoma Carcinoma, Non-Small-Cell Lung Adenoma N-monoacetylcystine Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Respiratory Tract Neoplasms Respiratory System Agents Neoplasms by Histologic Type Antioxidants Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Physiological Effects of Drugs Neoplasms, Nerve Tissue |
Protective Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Expectorants Therapeutic Uses Free Radical Scavengers Antidotes |