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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rijnstate Hospital.
Recruitment status was  Recruiting
Information provided by:
Rijnstate Hospital Identifier:
First received: March 11, 2008
Last updated: August 8, 2011
Last verified: August 2011
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
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:

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
Drug: N-Acetylcysteine
N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg
Other Name: Fluimucil
Placebo Comparator: 2
Drug: Placebo
Placebo once every 3 weeks intravenous saline fluid

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00637624

Contact: Idris Bahce, M.D. +31263788888 ext 3652
Contact: Hans Smit, MD +31263788888 ext 3030

Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6800TA
Contact: Idris Bahce, MD    +31263788888 ext 3652   
Principal Investigator: Idris Bahce, MD         
Sponsors and Collaborators
Rijnstate Hospital
Principal Investigator: Idris Bahce, MD Rijnstate Hospital
  More Information

Responsible Party: I Bahce, Rijnstate Hospital 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:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neurotoxicity Syndromes
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Nervous System Diseases
Chemically-Induced Disorders
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants processed this record on October 21, 2016