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N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy (NAC-PNP)

This study is currently recruiting participants.
Verified August 2011 by Rijnstate Hospital
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00637624
First received: March 11, 2008
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  Purpose

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 lung cancer 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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • The occurrence of peripheral neuropathy: with the peripheral neuropathy score (PNP-score) and the electrophysiological measurements. If no EMG is available, then audiometric measurements will be taken into account. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • haematological abnormalities [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • creatinine clearance. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • liver chemistry abnormalities [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Karnofski Performance Score [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
N-Acetylcysteine
 Drug: N-Acetylcysteine
N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg
Other Name: Fluimucil
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo once every 3 weeks intravenous saline fluid
Other Name: Placebo

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnose is histologically or cytologically proven (NSCLC,SCLC), malignant mesothelioma (histologically)
  • at least 4 cycles of cisplatin are planned
  • adequate renal function (creatinine clearance as calculated by Cockroft-Gault method > 60 ml/min)
  • Karnofsky performance score > 60 %
  • written informed consent
  • patient must be able to comply with study measurements i.e. hospital visits for EMG and QoL assessments
  • age ≥ 18 years

Exclusion Criteria:

  • patients with pre-existing neuropathy
  • patients not willing to stop earlier prescribed NAC
  • patients not willing to stop vitamins E and A above daily advisory dosage
  • uncontrolled metastasis in the central or peripheral nervous system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637624

Contacts
Contact: Idris Bahce, M.D. +31263788888 ext 3652 I.Bahce@vumc.nl
Contact: Hans Smit, MD +31263788888 ext 3030 HSmit@alysis.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6800TA
Contact: Idris Bahce, MD     +31263788888 ext 3652     I.Bahce@VUmc.nl    
Principal Investigator: Idris Bahce, MD            
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: Idris Bahce, MD Rijnstate Hospital
  More Information

No publications provided

Responsible Party: I Bahce, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT00637624     History of Changes
Other Study ID Numbers: LTC-510-100108-Bahce, CCMO: NL19614.091.07, EudraCT: 2007-002787-95
Study First Received: March 11, 2008
Last Updated: August 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
Acetylcysteine
Cisplatin
Neuropathy
Antioxidants

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Mesothelioma
Small Cell Lung Carcinoma
Neurotoxicity Syndromes
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Mesothelial
Nervous System Diseases
Poisoning
Substance-Related Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013