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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: | Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Efficacy Study, Parallel Assignment, Placebo Control, Prevention, Randomized |
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 |
---|---|
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
|
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 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Acetylcysteine Antioxidants Cisplatin Neuropathy |
Thoracic Neoplasms Antioxidants Neurotoxicity Syndromes Carcinoma, Neuroendocrine Antiviral Agents Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Expectorants Neoplasms, Germ Cell and Embryonal Lung Diseases Acetylcysteine Neuroepithelioma Mesothelioma Adenocarcinoma Carcinoma, Non-Small-Cell Lung Adenoma N-monoacetylcystine Neoplasms, Glandular and Epithelial |
Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms by Site Carcinoma, Neuroendocrine Neuroectodermal Tumors Thoracic Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Neuroendocrine Tumors Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms Neoplasms by Histologic Type Anti-Infective Agents Respiratory System Agents |
Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Respiratory Tract Diseases Therapeutic Uses Free Radical Scavengers Acetylcysteine Antidotes Protective Agents Antiviral Agents Pharmacologic Actions Carcinoma Carcinoma, Small Cell Lung Diseases Expectorants |