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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637624
Recruitment Status : Unknown
Verified August 2011 by Rijnstate Hospital.
Recruitment status was:  Recruiting
First Posted : March 18, 2008
Last Update Posted : August 9, 2011
Information provided by:
Rijnstate Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Lung Mesothelioma Drug: N-Acetylcysteine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : February 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. haematological abnormalities [ Time Frame: 5 months ]
  2. creatinine clearance. [ Time Frame: 5 months ]
  3. liver chemistry abnormalities [ Time Frame: 5 months ]
  4. Karnofski Performance Score [ Time Frame: 5 months ]
  5. Quality of life [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637624

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

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

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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
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011
Keywords provided by Rijnstate Hospital:
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neurotoxicity Syndromes
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